California
FAMILY PHYSICIAN
FAMILY PHYSICIANS ARE KEY TO HEALTHY MOMS, HEALTHY BABIES 12 2014 … THIS IS THE YEAR OF THE FAMILY PHYSICIAN
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CAFP’S LEGISLATIVE YEAR IN REVIEW: SCOPE, MICRA, MEDI-CAL – OH MY! 25 HUNDREDS OF THOUSANDS OF PEOPLE SEEK HEALTH CARE COVERAGE AT COVERED CALIFORNIA 28
VOL. 65 NO.1 Wint er 2014
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California Family Physician Winter 2014
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Start your FREE trial today! amazingcharts.com/trial 866-382-5932 California Family Physician Winter 2014 3
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Officers and Board
Staff
President Mark Dressner, MD
Allison Bauer
President-Elect Delbert Morris, MD
abauer@familydocs.org
Immediate Past President Steven Green, MD Speaker Jay Lee, MD, MPH Vice-Speaker Lee Ralph, MD
Leah Newkirk Vice President, Health Policy lnewkirk@familydocs.org
jdavis@familydocs.org
jcho@familydocs.org
Cynthia Kear, MDiv, CCMEP
Adam Francis
ckear@familydocs.org
Shelly Rodrigues, CAE, FACEHP
Senior Vice President
Deputy Director, Government Affairs
Deputy Executive Vice President
srodrigues@familydocs.org
Emma Lundberg
Kelly Goodpaster
Membership Coordinator elundberg@familydocs.org
afrancis@familydocs.org
shenry@familydocs.org
CMA Delegation Ashby Wolfe, MD, MPP, MPH Nathan Hitzeman, MD Michelle Quiogue, MD Suman Reddy, MD Kevin Rossi, MD Patricia Samuleson, MD
cmitcheltree@familydocs.org
Jerri Davis, CCMEP
Senior Manager, CME/CPD
Executive Vice President Susan Hogeland, CAE
AAFP Alternates Jeffrey Luther, MD Eric Ramos, MD
Student, Resident and Social Media Manager
shogeland@familydocs.org
Manager, Medical Practice Affairs
Sophia Henry
AAFP Delegates Jack Chou, MD Carla Kakutani, MD
Cody Mitcheltree
Executive Vice President
Jane Cho
Secretary/Treasurer Lisa Ward, MD
Foundation President Michael Rodriguez, MD, MPH
Susan Hogeland, CAE
Manager, Communications and Website
Abhinaya Narayanan
Associate Director, Membership and Marketing
Manager, Financial Services
kgoodpaster@familydocs.org
Workforce Development Manager anarayanan@familydocs.org
California FAMILY PHYSICIAN
Michelle Quiogue, MD, Editor Shelly Rodrigues, CAE, Managing Editor Allison Bauer, Manager, Communications-Website
Quarterly p publication of the California Academy of Family Physicians
Communications Committee: Michelle Quiogue, MD, Chair • Julia Blank, MD • Nathan Hitzeman, MD • Jeffrey Luther, MD
• Jay Mongiardo, MD • Albert Ray, MD
The California Family Physician (CFP) is published quarterly by the California Academy of Family Physicians (CAFP). Opinions are those of the authors and not necessarily those of the members and staff of the CAFP. Non-member subscriptions are $35 per year. Call 415-345-8667 to subscribe.
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California Family Physician Winter 2014
12 Family Physicians Are Key to Healthy Moms, Healthy Babies
Sarah Jones, MD, FAAFP
16 2014 … This Is the Year of the Family Physician
Ron Fong, MD
19 January 2014 Member of the Month Ronald L. Fong, MD, MPH, Sacramento, CA
Sophia Henry
25 CAFP’s Legislative Year in Review: Scope, MICRA, Medi-Cal – Oh My!
Adam Francis
28 Hundreds of Thousands of People Seek Health Care Coverage at Covered California
6
Editorial
Reflecting on Past Successes to Make 2014 Great
8
Presidents Message
“Go Out to Dinner for Valentine’s Day!”
9
PCMH Corner
2014: The Year Family Physicians Transform to the
Catherine Direen
Michelle Quiogue, MD Mark Dressner, MD
Patient Centered Medical Home 10 Foundation News
Leah Newkirk
CAFP Foundation’s Inaugural Class of Scholars is Already at Work
14 Political Pulse
New Laws in 2014 May Affect Your Patients and Practice
30 Executive Vice President’s Forum
Putting Patients First, to Infinity and Beyond
Shelly Rodrigues, CAE, FACEHP Ashby Wolfe, MD, MPP, MPH Susan Hogeland, CAE
For the upcoming CME calendar go to www.familydocs.org California Family Physician Winter 2014 5
edItorIal
Michelle Quiogue, MD
Reflecting on Past Successes to Make 2014 Great
Beginnings and endings are natural occasions on which to reflect, and this is both a beginning and an ending. It is the beginning of a new year and the end of my service as your editor, making it the perfect time to reflect on past successes and shortcomings in an effort to glean the lessons needed to make the coming year a greater success. When I look back on 2013, indeed when I reflect on my entire experience as editor, the meaningful moments that replay in my mind are those opportunities I had to make new connections and to strengthen trusted relationships in the family medicine community. California’s family of family docs will rely now more than ever on the value of relationships in 2014. Implementation of and participation in Covered California is a reality that all of us will need to negotiate. Across all modes of practice, physician livelihoods are at stake in both national payment reform legislation and California malpractice legislation. While there is no uniform solution, the successful protection of our individual interests hinges on our united efforts in the policy arena. In the year 2014, there can be no doubt about where family physicians stand on these vital issues. Practice transformation to a patient-centered medical home challenges family physicians to strengthen relationships with each member of the heath care team: patients, allied health professionals, hospital administrators and insurers. Team-based and collaborative medical neighborhoods are inherently complex and require both high tech and “high touch” solutions. In the year 2014, family physicians will lead most of these primary care teams and should lead accountable care organizations as well.
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California Family Physician Winter 2014
Primary care maldistribution and workforce shortage pressures have inspired the next generation of family physicians. Optimal intergenerational communication could lead to unimagined innovations without losing the wisdom and experience of the pioneering generation. Each of us bears the badges and scars of life-altering events that have shaped our world view. In the year 2014, there could be unlimited potential for professional growth if we open our minds and learn from the stories of each generation of family doctors. Relationships are the basis of our daily work. Each day, family physicians listen to countless stories of healing and caring, of suffering and loss. Trust is the most valuable currency of our profession. Trust is the basis of behavior change whether the focus is a patient, a colleague, a staff member or a legislator. Because the challenges physicians face in 2014 are great, reliance on the unique strengths of family medicine training and the core values of primary care is needed. For these reasons and more, the Academy invites all members to recognize 2014 as the Year of the Family Physician. We can take as our call to action the words former U.S. Surgeon General, and our family medicine colleague, Dr. David Satcher, once shared with the AAFP National Conference of Special Constituencies: “We must care enough. We must know enough. We must be willing to do enough. We must persist in our efforts.”
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Together, we can defeat diabetes in our lifetime. For more about us, visit novonordisk-us.com
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California Family Physician Winter 2014 7
PresIdent’s messaGe
Mark Dressner, MD
“Go Out to Dinner for Valentine’s Day!”
“I think the purpose of life is to be useful, to be responsible, to be honorable, to be compassionate. It is, after all, to matter: to count, to stand for something, to have made some difference that you lived at all.” ― Leo Rosten
This is a quote I used for the centerpiece of my essay to get into medical school. Back when I was an undergraduate trying to determine what I wanted to do with my life, this quote seemed to say it all. It still resonates for me today. Whenever I thought about medical school or being a physician, family physician was always what I imagined. NOW the year of the family physician has arrived. I have started all board meetings by encouraging a member of the board to share a patient story. I feel that this will keep us grounded. We have been privileged to hear touching stories from Patricia Moore-Pickett, Del Morris and William Woo. These stories are also the stories that I think make us stand out. They exemplify why family physicians are the breed that we are. As the Affordable Care Act hits our country in 2014, family physicians are the medical center of care in our country. This IS our year. I would like to share some of my patient stories to illustrate why we stand out. We all have these stories that, at the end of the day, make us feel good as we struggle with so many other aspects of providing healthcare. In residency I saw one of the faculty’s patients, a woman in her 60s experiencing chest pain. She had been diagnosed with Gastroesophageal Reflux Disease (GERD). She was so debilitated by pain that all she would do was sit on the couch, afraid to move. I admitted her, had her cathed, and angioplastied (it was the 80s; no stents). She left, chest pain free. In follow-up, she was physically fine but was still too scared to move much from her couch. I asked her and her husband if they would obey whatever I wrote on the prescription pad. They said “yes.” I wrote, “Go out to dinner for 8
California Family Physician Winter 2014
Valentine’s Day.” They promised– her first adventure outside their house. As I left residency, they came in, she nicely dressed. They had just purchased a recreational vehicle and were planning to travel the country. It wasn’t a medicine or a procedure that got her and her husband out and about, living again, but the physician’s understanding of her and her husband’s needs. Of course, today I would be judged by whether she was on aspirin and a beta blocker and not judged or graded on what I did as the family physician really to make a difference in this patient’s quality of life. I remember the cantankerous older woman who had seen most of the docs in the practice and did not get along with anyone. She had unexplained microcytic anemia and would not go along with anyone’s recommendations for workup. As I entered the room for our second appointment, I saw her constant scowl and asked “Have you even smiled yet today?” Talk about taking a risk on something to say to a patient!. Not only did this make her smile, she actually laughed. Our relationship had begun. I was her trusted physician until the end of her days. She ran all medical decisions past me and pretty much went along with whatever I advised. There was my patient who died of AIDS. I attended his funeral, one of 700 people filing into the church. I waited in line with my Licensed Vocational Nurse, surprised when the family sought me out to ask me to sit in the front row with them. I was the physician who had guided them and their loved one through the dying process. I currently have a Spanish-speaking rural Mexican immigrant couple who finally understand their diabetes – what they have to do and why. They constantly are competing for the lowest hemoglobin a1c. It is so fun to watch them on the edge of their seats as they await their latest numbers. Two of my patients are a Salvadoran couple. She flew to this country. He walked here. They have two beautiful children who are not my patients. Imagine my surprise when my patient said that her 11-year old daughter had something very important to show me. For a contest in her school she had written a story entitled, “My Mother’s Doctor.” It was all about her perceptions of me. What greater honor could there be? (Of course, I am working the pipeline, hoping that someday she, too, will be a family physician.) Our time has arrived: Patient Centered Medical Home, pay for performance, Sustainable Growth Rate, Medical Injury Compensation Reform Act, Graduate Medical Education Affordable Care Act…but it is what goes on with our patients in the room, behind closed doors, that is the most important and cannot be quantified. The year of the family physician has arrived!
Pcmh corner
Leah Newkirk
2014: The Year Family Physicians Transform to the Patient Centered Medical Home As the signature provisions of the Affordable Care Act (ACA) are implemented in 2014, there are new pressures on family physicians.Millions of Californians are gaining health insurance through an expanded Medi-Cal program and premium subsidies and cost-sharing reductions available through Covered California, putting increasing pressure on an already stressed health care workforce. Public and private payers are demanding “high-value” care – or demonstrably high-quality, low-cost care. An expectation exists that family physicians are using technology – electronic health records, e-prescribing, registries for population management and more – and penalties will be imposed on those who are not. Family physicians in 2014 can cope with these pressures by moving their practices to an advanced model of primary care: the Patient Centered Medical Home (PCMH). The PCMH is a way to address the varying requirements of modern health care in an organized way. The transformation process will enable you to build an efficient, team-based model for delivering care, maximize use of your current staff and possibly incorporate new staff positions such as care managers. The transformation process will help you to use technology “meaningfully” and enhance your quality reporting to payers. The transformation process will increase your quality, thereby increasing your “value” and payment. Public and private payers want you to be a PCMH. The ACA establishes a value-based payment modifier to increase payments for Medicare physicians who deliver high-value care and decrease payments for low-value physicians, effective in 2015. The California Health and Human Services Agency, in its State Health Care Innovation grant application, is proposing a multi-payer “Health Homes for Complex Patients Initiative.” Covered California required plans offering products on the Exchange to submit data on the percentage of in-network primary care practitioners recognized as PCMH at the start of the plan year. Nationally, health plans are rolling out payment that rewards highvalue or advanced primary care: • United Health Care is offering new “value-based” contracts to 550,000 physicians in its network whom the company deems high-quality and efficient. • Wellpoint (Anthem Blue Cross) announced a new program that will increase the company’s investment
•
in primary care practices. Payment for some specific physician services is initiated and shared savings are offered to practices meeting quality requirements and reduced medical costs. Aetna is paying a network of 55,000 primary care physicians an extra, non-volume-based fee for recognition as PCMH by the National Committee for Quality Assurance (NCQA).
It will not be long before these payment models are rolled out in California. Health care reform and payment aside, PCMH is the way to provide better care for your patients and improve your patients’ health. In CAFP’s Fresno PCMH pilot, the primary care provider group, Community Medical Providers, saw improvements in almost every quality measure within the first six months. Patients with diabetes and heart disease saw improvements in their care and health. The selfinsured employer supporting the pilot saw net savings of approximately one million dollars attributable to reductions in in-patient hospital days. Make 2014 the year you transform your practice; CAFP is ready to help. CAFP has made practice transformation coaching and web-based support services available to meet the needs of our member physicians in their diverse practices. We have two partnerships with transformation consulting firms– HealthTeamWorks and Arcadia Solutions. These consulting firms offer in-office quality improvement coaching; experience developing PCMH pilots, demonstrations or initiatives; training and mentoring of internal quality improvement coaches; and assistance with NCQA Recognition. Contact Jane Cho at jcho@familydocs. org to learn more. And CAFP is building a PCMH University, where you can learn more about the model and take Continuing Professional Development (CPD)-accredited courses that move you in the right direction. You can read a business case for the PCMH and learn about how CAFP built our Fresno PCMH pilot. You can connect with other family physicians who are transforming or find inspiration from those who have taken great strides forward. 2014 is your year for change. CAFP offers the tools to do it!
California Family Physician Winter 2014 9
FoundatIon news
Shelly Rodrigues, CAE, FACEHP, CAFP Foundation Executive Director
CAFP Foundation’s Inaugural Class of Scholars is Already at Work
In 2013 the CAFP Foundation (CAFP-F) inaugurated a new program for medical students called the CAFP Foundation Scholars. The Scholars program is an outgrowth of the very successful summer preceptorship program established in the early 1990s to introduce medical students to family medicine. The Scholars program is a longitudinal experience for 20 firstyear medical students with a strong interest in family medicine and primary care. The three-year program gives students the opportunity to engage with the Academy at a variety of levels. Each medical student is also paired with a family physician mentor who will stay with the student throughout medical school. Scholars build relationships with other medical students interested in family medicine, receive financial support to attend select CAFP/AAFP events, and develop a close relationship with practicing family physicians in California. The Scholars Program begins with a four-week preceptorship opportunity with a family physician. CAFP staff and medical school coordinators work with students to determine individual preferences, including practice type and location, and do their best to match students with the best preceptors available. Small living-expense stipends are available to students traveling far from their home or school location on an as-needed basis. After the completion of the four-week preceptorship experience, students attend numerous events, and are required to submit articles to CAFP publications, such as the Family Medicine Revolution blog or California Family Physician magazine. Students also choose between completing a project in research, community service or preparing an additional article for publication. During the Family Medicine Summit immediately following the summer preceptorship, Scholars are matched with faculty mentors who will follow the class throughout medical school and Scholars experience. Faculty members are selected for their experience in mentoring medical students and their enthusiasm for practicing family medicine. Students will be in regular contact with their faculty mentors and will have the opportunity to get together at CAFP events throughout the year. Each faculty member is eligible to receive up to 20 CME credits for teaching and will be recognized for their participation each year. Responsibilities will include staying in touch with their
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California Family Physician Winter 2014
cohort via social media or email as well as attending CAFP events with their students each year. We hope our faculty mentors will develop long-lasting relationships with students that might even evolve into job opportunities in the future. CAFP Foundation pays travel expenses for students and mentors for all mandatory Scholar events and have some limited additional funding for research projects on an as-needed basis. The 2013 inaugural class includes: Brandon Cortez, University of California - San Diego Brittany Fernandez, Western University of Health Sciences, College of Osteopathic Medicine of the Pacific Alexandra Gits, Eastern Virginia Medical School Gabriela Moriel, Keck School of Medicine of USC Laura Murphy, Western University of Health Sciences College of Osteopathic Medicine of the Pacific Ryan Nguyen, Western University of Health Sciences College of Osteopathic Medicine of the Pacific Shaudee Parvinjah, University of California, Irvine Sarah Petrie, Touro University College of Osteopathic Medicine Leah Phan, Touro University College of Osteopathic Medicine California Teresa Robbins, University of California, San Diego Kristen Roehl, Keck School of Medicine of USC Debra Wang, UC Irvine Meghan Ward, Keck School of Medicine, USC Esther Wu, Touro University - College of Osteopathic Medicine, California Alicia Zhou, Touro University College of Osteopathic Medicine California Interested in applying for the 2014 class? Want to be a mentor to one of these bright FM stars? Please contact Cody Mitcheltree, cmitcheltree@familydocs.org. CAFP will also hold a special “How to be a Great Mentor” session for family physicians interested in serving as mentors – the 2 hour session will be held Sunday, March 2, 2014, during the All Member Advocacy Meeting in Sacramento. No charge for any CAFP member. Contact Shelly Rodrigues, srodrigues@familydocs.org for more information.
In the news “WHEN I HAVE AN
CAFP’s Congress of Delegates is now the to physicians and teaching hospitals to All Member Advocacy Meeting (AMAM) the Centers for Medicare and Medicaid and is open to all family physician Services (CMS) beginning August 1, members from every part of the state! 2013. CMS will publish this information The AMAM will be held at the Citizen in a public online database beginning Hotel in downtown Sacramento, Saturday in September 2014 after registered and Sunday, March 1-2, 2014 followed by physicians are given an opportunity to CAFP Lobby Day on Monday, March 3. The review it for accuracy. The American meeting will feature exciting interactive Academy of Family Physicians and CAFP, sessions on hot topics like health care American Medical Association (AMA) and reform, graduate medical education CMS have pledged to provide up-to-date funding, Covered California, the medical information and resources to physicians home and more. The meeting features fun as they begin the reporting and review training sessions to give you all the tools periods and as they communicate with you need to advocate for family medicine patients about the public reporting at home and in the Capitol. The meeting results/efforts. CAFP will do its best also offers the opportunity to interact to keep you posted – when we hear, AMERICAN ACADEMY OF FAMILY PHYSICIANS with legislators in a relaxed, informal we’ll make sure you hear! For more 5.1250 x information 4.8750 (4clr) visit www.familydocs.org environment. Click here to register online. baf/rv/gl/æ/mr
CAFP awarded ACCME Reaccreditation with Commendation by ACCME! The CAFP received word that the Accreditation Council for Continuing Medical Education has awarded its CME/CPD program Accreditation with Commendation. The ACCME Board of Directors approved the six-year accreditation based on review of the self-study report, evidence of performance-in-practice and the accreditation interview. Accreditation with commendation is given to providers that demonstrate compliance with all 22 Criteria and the accreditation policies. CAFP was commended as a learning organization with commitment to change and improvement. Congrats to Team CME: Cynthia Kear, Jerri Davis and Shelly Rodrigues and the entire CCPD: Drs. David Bazzo, Carol Havens, Lenny Lesser, Chris Flores, Tom Bent, Ashley Christiani, Tipu Khan, Lee Ralph, Will Woo, Geoff Leung, plus our consultants Drs. Mike Potter and Martin Quan. Implementation of the Affordable Care Act includes the Physician Payment Sunshine Act – a means of creating public transparency into industry-physician financial relationships. Sunshine requires manufacturers of drugs, devices, biological and medical supplies covered by federal health care programs to report payments and other “transfers of value”
ASTHMA ATTACK I FEEL LIKE A FISH
WITH NO WATER.” –JESSE, AGE 5
SF020791B
5
1/1/2014 MRAMIREZ
A
January Issue ATTACK ASTHMA. ACT NOW.
1- 866 - NO -ATTACKS
W W W. N O AT TA C K S . O R G
CDDIS 10/01
Alameda Health System (AHS) is a major integrated community health care provider and medical training institution recognized for its world-class patient and family centered system of care. Highland Hospital, the flagship hospital of Alameda Health System, is a trauma center as well as a nationally recognized teaching institution affiliated with the University of California, San Francisco medical school. Since its founding, the organization has continually served the health care needs of Alameda County guided by its mission of Caring, Healing, Teaching, Serving all. Family Physicians – Board Certified Urgent Care and Integrative Medicine Seeking Ambulatory Care Physicians for our newly opened Same Day Clinic (Urgent care), a key attribute of the new Highland Care Pavilion and our Hayward Wellness Center’s new stateof-the-art building, designed to support and increase access to holistic, patient-centered and innovative care. Qualified candidates will have a MD or DO, board certification and a valid (or in progress) CA license. Medical Director, Eastmont Wellness Center Practices as an active medical staff member, organizes and directs medical and professional services, performs annual provider evaluations, participates in strategic and financial analysis of clinical programs and services offered, and participates in the development and implementation of electronic data management systems. Experience as a medical director or site leader in an ambulatory care setting strongly preferred. To apply, please send your resume to: Maria Knutson, mknutson@alamedahealthsystem.org or call: 510-895-7397. You may also visit our website for more information: www.alamedahealthsystem.org. We are an equal opportunity employer. California Family Physician Winter 2014 11
PublIc health and you
Sarah Jones, MD, FAAFP
Family Physicians Are Key to Healthy Moms, Healthy Babies “Will it hurt?” “Once it’s in, I don’t think so.” Jessica is a 15-year-old soccer player not faring so well on birth control pills, and they make her migraines worse. Her cycles are regular, but painful and heavy. She’s interested in alternative contraception. Her teammate recently had a Nexplanon inserted, and she wonders if she should, too. She certainly doesn’t want to hear any more about the Mirena IUD—“that would be too weird,” she says. But she’s open to a subdermal device that could make her monthly menses more manageable and protect her from unintended pregnancy. So...does this scenario fit your notion of preconception care? What resources can we use to talk about family planning, life planning, preconception care, interconception care? As a family physician who has provided obstetrical care for 15 years, I am honored to serve as the CAFP representative on the Preconception Health Council of California, which began in 2006 as a joint effort among the American Congress of Obstetricians and Gynecologists ACOG, District IX (CA), the California Department of Public Health (Maternal Child Adolescent Health Division), and March of Dimes. Its mission is to engage individuals, communities and policymakers to optimize the health and well-being of women and their partners, leading to healthier infants and families. Since 2006, this council has become a veritable “stone soup” with other government and private members entering the mix. To promote healthy pregnancies, we have collected a variety of resources to help physicians, some of which are highlighted below. Why is promoting healthy pregnancy important? Because unplanned pregnancy and late prenatal care are major public health issues in California. Over half of pregnancies are unplanned, and half of pregnant women suffer from at least one medical condition (asthma, diabetes, Human Immunodeficiency Virus (HIV), etc.). The national website www.beforeandbeyond.org gives links to many toolkits, such as history and physical templates, tips for counseling women with alcohol abuse, family tree tools, nutrition help and guidance for health conditions such as thyroid disease or HIV. For fish consumers, a nifty mercury calculator can be found at http://www.nrdc.org/health/effects/mercury/protect.asp. On our state website www.everywomancalifornia.org, we used the “Ask, Advise, Refer” format to create a two-page PDF that addresses more than 20 specific health conditions. 12
California Family Physician Winter 2014
Figure: Introduction page and example guideline from Specific Health Conditions www.everywomancalifornia.org One can imagine all the questions that come up surrounding pregnancy and family planning. Which psychiatric or seizure medications are safe; how much does diabetes increase risk of complications; which HIV meds reduce efficacy of Oral Contraceptive Pills; what is the partner abuse hotline; where can one find resources for genetic disorders and information on toxins? Answers can be found in this downloadable document. Links to videos, nutritional guidance, contraception and maintaining wellness are on the patient web pages. As family physicians we have sequential opportunities to build relationships and deliver messages that “stick.” Now we have even more readily-available guidelines to assist us. Catchy phrases such as “Healthy Body, Healthy Mind, Healthy Environment,” need to be put into action with concise and opportune counseling. Consider incorporating clinical pearls into templates in your electronic health record—they can be woven into well-woman exams or standard office visits. Together, we can positively affect tomorrow’s generation. Other resources: Farahi N, Zolotor A. Recommendations for Preconception Care and Counseling. Am Fam Physician. 2013 Oct 15;88(8):499-506. http://www.aafp.org/afp/2013/1015/p499.html http://www.cdc.gov/preconception/index.html - CDC’s sites for preconception health Sarah Jones, MD, FAAFP is faculty at the Sutter Family Medicine Residency Program and serves on the Preconception Health Council of California. She is passionate about providing personalized maternity care and teaching obstetrics to residents in the US and to health care workers in Ethiopia.
HuNGEr kEEps up oN currENt EVENts, too.
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Claim
Heritage
The Center for the History of Family Medicine is devoted to preserving and sharing the history of family medicine. Through exhibits, research, and reference services, the Center promotes family medicine’s distinguished past and looks forward to its promising future. Claim your family medicine heritage!
1 IN 6 AMErIcANs struGGlEs WItH HuNGEr.
www.aafpfoundation.org/chfm CENTER FOR THE
HISTORY
O F FA M I LY MEDICINE
toGEtHEr WE’rE
C L A I M Y O U R H E R I TA G E
Hunger is closer than you think. reach out to your local food bank for ways to do your part. Visit FeedingAmerica.org today.
Mead Johnson “Doctor’s Office A Century Ago” Exhibit at AAFP Headquarters. 1975-1984, from CHFM photo collections.
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California Family Physician Winter 2014 13 AM 5/14/13 11:41
Ashby Wolfe, MD, MPP, MPH
PolItIcal Pulse
New Laws in 2014 May Affect Your Patients and Practice With the start of a new year, we want to alert our members to laws passed last year that may affect your patients and practice. AB 2109 (Pan): Immunization Exemption for Communicable Diseases This new law passed in 2012, but will be implemented in 2014. The law requires documentation that health care practitioners have informed parents about vaccines and diseases before obtaining exemptions to student immunization requirements based on personal beliefs. CAFP did not take a position on this bill. While CAFP fully supports the effort to increase immunization rates, strong evidence showing the strategy used in AB 2109 is effective in achieving that goal is not available. Parents or guardians seeking an exemption to an immunization required for California students will need to document: • The receipt of information about immunizations and communicable diseases from authorized health care practitioners, who are also required to document their provision of such information. This documentation may not be signed more than six months prior to when immunization is required (typically, the start of the school year; and • Required immunizations the student has or has not received. Authorized health care practitioners will include licensed physicians, nurse practitioners, physician assistants, naturopathic doctors and credentialed school nurses. AB 446 (Mitchell): Mandatory HIV Testing This new law requires that every patient who has blood drawn in a primary care clinic be offered an Human Immunodeficiency Virus (HIV) test. Patients have the right to decline, but if they accept, documentation of specific counseling must be completed. For family physicians, especially those who work in an electronic system, these changes likely will be beneficial, but, overall, the testing will be more extensive. The counseling specifically includes a review of the available treatment options if the test result is positive. If negative and the patient is engaged in high risk behaviors, the counselling includes describing the importance of repeat and frequent testing. If a patient independently requests the test, the physician is exempt from documenting the counseling itself. Finally, the law authorizes Internet delivery of HIV results unless the patient requests to receive results through a different method. AB 1000 (Wieckowski and Maienschein): Direct Access to Services of Physical Therapists This new law is a combination of two separate but related bills that address a November 2010 Physical Therapy Board decision 14
California Family Physician Winter 2014
that reversed decades-old policy allowing physical therapy services to be provided by medical corporations. Nearly 80 percent of physical therapists work in medical corporations, hospitals, home health care services and nursing care facilities. This bill was a compromise between the physical therapists and the California Medical Association (CMA). It struck a balance between ensuring medical corporations’ ability to employ physical therapists under the Business and Professions Code, the Chiropractic Act and the Osteopathic Act, and allowing patients to have direct access to physical therapy services without a referral for 45 calendar days or 12 visits, whichever comes first. After 45 days or 12 visits, the patient must receive an in-person examination from a physician or podiatrist, who must also sign off on the physical therapist’s plan of care. AB 1308 (Bonilla): Midwifery This bill was sponsored by the California Chapter of the American Congress of Obstetricians and Gynecologists (ACOG) with the goal of bringing clarity to the practice of midwifery and separating it from the practice of medicine. CAFP and others worked with ACOG to ensure the best outcome for patients. As a result, the following changes to current law were included in the bill: • Limiting midwife-led home births to normal pregnancies; • Creating client disclosure and informed consent requirements; • Requiring outcomes reporting; • Improving the intrapartum transfer process; and • Removing physician supervision, replaced by patientphysician consultation in high risk cases. Though fewer than 300 midwives are licensed in California, and this bill would only affect about 2,000 births a year, it was important to address and clarify the practice of midwifery legislatively. In addition to the new laws above, Governor Jerry Brown signed four bills on which CAFP had a “Support if Amended” position. While CAFP saw many positive aspects to the bills, lingering concerns prevented the Legislative Affairs Committee and Board from moving CAFP into a full “Support” position. These bills will become law next year and CAFP will closely monitor their implementation and take action should our concerns come to fruition. • AB 154 (Atkins) will allow a nurse practitioner (NP), certified nurse midwife (CNM) or physician assistant (PA) to perform an abortion by aspiration in the first trimester of pregnancy upon completion of specified training and validation of clinical competency. These providers were previously only authorized to perform an abortion by medication. A multi-year study conducted by the University of California,
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San Francisco’s (UCSF) Bixby Center for Global Reproductive Health, under a waiver from the Office of Statewide Health Planning and Development, evaluated the safety, effectiveness and acceptability of the procedure and found mainly positive results. CAFP sought to amend the bill to ensure that all mid-level practitioners acquire at least the same level of training as those who participated in the UCSF pilot and to require that the procedure take place only under protocol. We secured both amendments, but the training requirement will sunset after two years and be replaced by a yet-to-bedetermined standard. AB 361 (Mitchell) will authorize the Department of Health Care Services (DHCS) to establish a pilot program to provide “health home” services to Medi-Cal enrollees with chronic conditions, as allowed under Section 2703 of the Affordable Care Act (ACA) . As part of this program, the state would receive a 90/10 federal-to-state dollar match to pay for “health home services” not already being provided to patients. CAFP sought amendments to ensure that the definition of health home was as close to the Joint Principles of the Patient Centered Medical Home (PCMH) as possible. While the law contains some elements of the Joint Principles, key aspects such as a “Personal Physician” and “Physician-Directed Medical Practice” were not included. SB 494 (Monning) will allow a physician or physician group to increase their patient panel size by an additional 1000 patients for every nurse practitioner or physician assistant supervised by that physician or group. While CAFP supports the effort to recognize the increased capacity of efficient health care teams, we raised concerns that this might create a loophole for insurance companies looking to claim larger network capacity than they actually have. The law will sunset at the end of 2018 to ensure that, if network adequacy concerns are discovered, the additional allocation could be eliminated.
Join us on California's Central Coast! Community Health Centers of the Central Coast, a FQHC network located on the beautiful Central Coast of California, is seeking Board Certified Family Practice Physicians. Qualifications: Active, unrestricted CA license and DEA, Board Certification. Competitive salary and incentive structure; excellent benefits package. State and federal loan repayment available.
Please send inquiries and CV/cover letter to Sarah Willingham at sarahw@chccc.org. For additional information, visit our website
communityhealthcenters.org and click on the "Careers" link.
More than just filling vacancies... Itʼs about matching lifestyles, personalities and practice philosophies. Locum Tenens & Physician Staffing
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Ron Fong, MD
2014 ‌ This Is the Year of the Family Physician What is #2014yearfp? Larry Bauer, CEO of the Family Medicine Education Consortium has posed that question to me over the past few months. Deftly, he noted that it had to be more than just a bumper sticker. Why should the general public care about family physicians in the upcoming year? I have proposed that #2014yearfp is a compass and a beacon to help us navigate through the uncharted territories of the Affordable Care Act. Does that answer have meaning, value and relevance to our patients, however? For the majority of them, I suspect not. Since we prioritize patient-centeredness in our discipline, let us infuse that tenet into #2014yeafp. We start by inviting our community to join us in a celebration. We celebrate the beginning chapters and milestones of life. We welcome the arrival of a child into the world. We gush at a baby’s first words and steps. We mark the passage of children into adulthood. We bear joyful witness to the unions of matrimony. We honor our elders as they retire from their vocation. In some faiths, the end of life on earth and the ascension into a higher spiritual plane is celebrated. Life is a series of celebrations. As family physicians, we journey with our patients on many of them. #2014yearfp is a tapestry of all that we hold dear and extend to others with open arms and hearts. It is a bond of universal and unique experiences. #2014yearfp is about drawing a breath and pausing to see what is right before us. Take a moment and look at your mentors, colleagues and charges and revel in the energy that sustains us as family physicians. Look to your patients and cherish how their trust has given us direction and purpose in life. Look toward the future and walk toward a better tomorrow. And, this celebration is one of inclusion. We invite all within our circles to expand and to enhance them. In light of celebrating the New Year, I am inviting all to join me in a global celebration. Round up your fellow family physicians and gather at a place that is the epicenter of your professional lives. Light a candle at midnight to ring in not just a new year, but a new era. As fireworks illuminate our dreams, and horns, bells, and whistles serenade our hopes, stop and
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California Family Physician Winter 2014
2014
YEAR OF
THE
FAMILY
PHYSICIAN
commemorate the moment that 30 million Americans are now eligible for health insurance. In a blink of an eye and a beat of the heart, we have 30 million more narratives to hear, 30 million more needs to tend and 30 million more opportunities to celebrate who we are as family physicians. #2014yearfp is a gift. It is a gift to all my colleagues who have made family medicine an institution of comprehensive compassion. I urge you to pass along this gift to your patients and to your community and I hope the adage of it is better to give than to receive will ring true for you. Dr. Fong is director of the UC Davis Family Medicine Residency Network. His opinions are his own and do not represent UC Davis. He can be reached at ronald.fong@ucdmc.ucdavis.edu.
Want to get involved with #2014YearFP? Follow these three simple steps to participate and help spread the word that 2014 is indeed The Year of the Family Physician.
Cut out the #2014YearFP Signboard! Take a Picture! Feel free to get creative; Both group shots and selfies are welcome! The important thing is that the message is clear and visible.
Send CAFP your photo!
Cynthia Kear in Lampang, Thailand at the Thailand Elephant Conservation Center.
Tweet or Instagram your photo by using the hashtag #2014YearFP. You can also post it to the CAFP Facebook wall.
Mark Dressner, MD with staff at The Children’s Clinic. Susan Hogeland, CAE in Punta Laguna, Mexico.
From Left to Right: Jack Tsai, MD, Brian Kawasaki, MD, Don Lassus,MD, Jyoti Puvvula, MD at Harbor-UCLA Family Medicine program. From Left to Right: Shelly Rodrigues, CAE,FACEHP, Bo Greaves, MD, Susan Hogeland, CAE Albert Ray, MD
California Family Physician Winter 2014 17
2014
YEAR OF
THE
FAMILY
PHYSICIAN
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California Family Physician Winter 2014
Sophia Henry
January 2014 Member of the Month Ronald L. Fong, MD, MPH Sacramento, CA CAFP’s Member of the Month program recognizes one outstanding CAFP member who champions family medicine in their daily practice life. This month, we honor Dr. Ronald Fong, MD, MPH. Dr. Fong is an associate clinical professor and the network director of UC Davis’ Family Medicine Residency Network and serves as a Key Contact with CAFP. He is also the founder of 2014 Year of the Family Physician and author of “2014YearFP”—a family medicine advocacy blog at fmrevolution.org. Biography CAFP’s Member of the Month program recognizes one outstanding CAFP member who champions family medicine in their daily practice life. This month, we honor Dr. Ronald Fong, MD, MPH. Dr. Fong obtained his B.S. degree from the University of California, Irvine before graduating from Wayne State University School of Medicine. He subsequently completed a family medicine residency at the King/Drew Medical Center in Los Angeles. After completing fellowships in clinical hypertension, nephrology and primary care outcomes research, he joined the faculty of the UC Davis Department of Family & Community Medicine in 2005.
CAFP: Tell us more about 2014 Year of the Family Physician. What inspired you to create this movement? RF: The Affordable Care Act has been implemented, and 30 million more Americans will receive health insurance and seek out the services of a family physician. 2014 Year of the Family Physician is an opportunity for family physicians to demonstrate that we provide the highest level of care with the most efficient use of resources to patients. CAFP: In your 2014YearFP blog, you raise awareness about the importance of family physicians and urge others to do the same. How do you envision taking this message to the next level with 2014 Year of the Family Physician? RF: I was inspired by Jay Lee’s use of social media in his #FMRevolution platform. With #2014yearfp we will chronicle how family physicians are shouldering a greater proportion of America’s health care needs. CAFP: What is your greatest goal for 2014 Year of the Family Physician? RF: I hope it will motivate people to speak up and support the growth of family medicine. By promoting #2014yearfp, we can ensure that health insurance leads to health care. CAFP: Why did you choose family medicine? Can you describe why you are so passionate about it? RF: It allows me to have a fulfilling narrative to my life. I work side-by-side with patients, instead of dictating a course of action to them.
Dr. Fong has led federally and privately funded research studies focusing on improving outcomes in diabetes and hypertension control since joining the department. He currently serves as the director for the UC Davis Network of Affiliated Family Medicine Residency Programs and is also the faculty advisor to the resident advocacy group.
CAFP: As a full-time physician, advocate for family medicine, and Director of UC Davis family medicine residency network, you have a pretty full plate—how do you do it all? RF: To me, it is not about work-life balance; it is about work-life harmony. Practicing family medicine should be an extension of a physician’s core values and a means to expand one’s identity.
Dr. Fong serves as a Key Contact with CAFP and is also a member of Congresswoman Doris Matsui’s Sacramento Health Care Working Group. The group functions to aid Congresswoman Matsui’s office outreach efforts in implementing the Affordable Care Act in the Sacramento region. He resides in his hometown of Sacramento with his wife and three sons.
Each month, CAFP highlights one outstanding California family physician member who lends their voice, time, talent and resources to strengthen the Academy, the specialty of family medicine and his or her community. If you would like to share your story or know a family physician colleague who deserves to be recognized for his or her impact or leadership, contact CAFP at 415-345-8667 or cafp@familydocs.org. California Family Physician Winter 2014 19
PHYSICIAN – FAMILY MEDICINE Vista Community Clinic located in North San Diego County
MED7 has been providing urgent care services in the Greater Sacramento area since 1987 Urgent care clinics are located in Roseville, Carmichael, Folsom & North Sacramento. Board Certified or Board Eligible in family practice or emergency medicine. All shifts 9am to 9pm. Full time is 13 shifts per month. We offer our full time physicians the following: full malpractice coverage, medical & dental coverage at no cost for the physician & any dependents, disability policy & we have a simple IRA you can contribute to with 3% matching. Part time is 6 to 8 shifts per month. There is no call. There is no tail coverage that needs to be purchased should you leave our employment. We have a single policy that continues on after you leave. If something were to arise here after you left our employment, you would be covered.
Seeking: Full-time, part-time and per diem Family Medicine Physicians. Requirements: California license, DEA license, CPR certification and board certified in family medicine. Bilingual English/Spanish preferred. Contact Us: Visit our website at www.vistacommunityclinic.org Forward resume to hr@vistacommunityclinic.org or fax resume to 760-414-3702
ContaCt
Michelle Gilbert
mgilbert@pcipublishing.com
California Family Physician Winter 2014
Family Practice:
Grass Valley, Redding, Sacramento, Santa Cruz, Stockton
For Advertising
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At Dignity Health Medical Foundation, we lead by example. By always striving to give our personal best—and encouraging our patients and colleagues to do the same—we’re able to achieve and do more than we ever imagined. If you’re ready to inspire greatness in yourself and others, join us today.
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For more information about MED7 and our clinics please visit our website: www.med7.com We offer an attractive compensation package.
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Our locations offer access to outstanding schools, exciting recreational opportunities and a wide variety of cultural events. Our physicians utilize leading edge technology, including EMR, and enjoy a collegial and supportive environment. We also offer a competitive compensation & benefits package which includes bonus potential and a very desirable retirement plan. For more information, please contact: Physician Recruitment Phone: 888-599-7787 Email: providers@dignityhealth.org www.dignityhealth.org
PHYSICIAN – OBSTETRICS AND GYNECOLOGY
Vista Community Clinic located in North San Diego County Seeking: Part-Time and per diem OB/GYN Physicians. Requirements: California license, DEA license, CPR certification and board certified in obstetrics and gynecological medicine. Bilingual English/Spanish preferred. Bilingual English/Spanish
Contact Us: Visit our website at www.vistacommunityclinic.org Forward resume to hr@vistacommunityclinic.org or fax resume to 760-414-3702
health.org
2014 Annual Scientific Assembly May 9-10, 2014 | Renaissance Esmeralda | Indian Wells, CA
Registration is open for CAFP’s 66th Annual Scientific Assembly and you won’t want to miss it! The 2014 meeting will be held at the beautiful Esmeralda Renaissance Hotel in Indian Wells, CA. The hotel includes spacious rooms, a huge pool (with a sandy beach at one end) and outdoor snack bar, fire pits with conversation couches, a spa, two restaurants and a newly renovated Kid's Club. CAFP has negotiated a $195/night conference rate for the hotel. The 2014 ASA includes six extended sessions: 90-minute blocks on topics as wide ranging as End-of-Life and Palliative Care Discussions, Tackling Obesity, Infectious Diseases, and Keeping Your Senior Patients Well. We've also planned six TED Talks, two SAMS Groups, a Botox-Derm Abrasion workshop and two pre-conference seminars!
To Make a Reservation: Visit www.familydocs.org or Call CAFP at 415-345-8667 or Scan the QR code
Reserve your seat at the family medicine table! California Family Physician Winter 2014 21
PROVEN. LOW RATE OF HYPOGLYCEMIA
POWERFUL A1C REDUCTIONS -0.8% to -1.5%*
MAY PROVIDE ADDITIONAL BENEFIT OF WEIGHT LOSS†
For adult patients with type 2 diabetes, Victoza® offers these benefits and more. Visit VictozaPro.com/Care to learn how the support program helps patients get started.
*Victoza® 1.2 mg and 1.8 mg when used alone or in combination with OADs. † Victoza® is not indicated for the management of obesity, and weight change was a secondary end point in clinical trials.
Indications and Usage
Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin.
Important Safety Information
Liraglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
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California Family Physician Winter 2014
Do not use in patients with a prior serious hypersensitivity reaction to Victoza® (liraglutide [rDNA origin] injection) or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. Please see brief summary of Prescribing Information on adjacent page.
0513-00015592-1
June 2013
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-
ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2
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Constipation Dyspepsia
5.3 0.9 1.7 5.2 0.9 2.6 Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone Placebo + Metformin + Rosiglitazone All Victoza® + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Victoza® 1.8 mg once daily + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, 24
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the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Glimepiride + Placebo + Metformin Add-on to Metformin Victoza + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + ® Metformin Victoza + Metformin + Metformin alone (N = 163) (N = 158*) 0 0 — Patient not able to self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat Patient able to self−treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 ® Placebo + Metformin Add-on to Metformin Victoza + Metformin + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) 0 — 0 Patient not able to self−treat Patient able to self−treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) ® Add-on to Metformin Victoza + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + + Glimepiride + Glimepiride (N = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015681-1 5/2013
CAFP’s Legislative Year in Review: Scope, MICRA, Medi-Cal – Oh My! By Adam Francis CAFP’s Associate Director, Legislative Affairs
The first year of the 2013-2014 Legislative Session was very successful for CAFP. Thanks to the effort of CAFP Key Contacts, physician leaders and staff, the Governor signed 19 CAFP-supported bills. In addition, every bill CAFP opposed was either amended to remove our opposition or failed to pass in the Legislature. CAFP also secured changes to legislation without formally
opposing bills, as legislators and legislative staff sought CAFP guidance on bills that could have had unintended negative consequences. Scope of practice expansion battles took a significant amount of effort and resources to defeat, but defeat them we did! The author was intent on seeing how far in the legislative process he could take the original language of the bills without making any concessions to the opposition. This led to a long, grueling legislative fight with both sides digging in hard. Several other themes emerged this legislative year in addition to scope expansion:
The Trial Attorneys Are Ready for a MICRA Fight Late in the 2011-2012 Legislative Session, CAFP and our allies prevented two anti-MICRA bills from reaching the Governor’s desk as part of a coalition effort led by the Californians Allied for Patient Protection (CAPP), the state’s leading pro-MICRA organization. The Medical Injury Compensation Reform Act (MICRA) is California’s professional liability law that, for more than 35 years, has ensured that patients receive all economic damages and medical care to which they are entitled, but limits noneconomic damages (so-called pain and suffering awards) to $250,000 and caps awards to trial attorneys on a sliding scale basis. The groundwork our coalition did in educating legislators in 2011-2012 proved fruitful, as no legislation affecting MICRA was introduced this year. That said, the pressure from consumer groups and the trial attorneys continues. A ballot measure was filed in late July that, pending qualification and voter approval, would not only weaken MICRA, but also require; • Physicians to report substance abuse or medical negligence by other physicians; • The removal of the current non-economic damages cap, increasing potential non-economic damages to up to $1.1 million and allowing that amount to rise with inflation; and
The first year of the 2013-2014 Legislative Session was very successful for CAFP. Thanks to the effort of CAFP Key Contacts, physician leaders and staff, the Governor signed 19 CAFPsupported bills. In addition, every bill CAFP opposed was either amended to remove our opposition or failed to pass in the Legislature.
• Random drug and alcohol testing on physicians. The measure needs more than 500,000 valid voter signatures to qualify for the 2014 general election ballot. CAFP and our allies will remain vigilant to guard against any legislation next year and are gearing up to oppose the ballot measure should it qualify for the November 2014 ballot. California’s Budget Is Back on Track With the success of CAFP-supported Proposition 30 on the November 2012 Ballot, California immediately improved its financial outlook. The billions of dollars generated for the General Fund significantly helped to address the state’s budget crisis that had forced legislators and the Governor to make devastating reductions to programs for consecutive years. The improved financial standing allowed for a budget that held reason for optimism for family physicians and their patients. Among some of the budget provisions were • A 4.9 percent increase in funding for In-Home Supportive Services; • A cost of living increase in Supplemental Security California Family Physician Winter 2014 25
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Income/State Supplementary Payment (SSI/SSP) grants for low-income elderly, blind and disabled beneficiaries; $80 million to partially restore Medi-Cal adult dental benefits (full restoration would cost $130 million). The money will provide preventive care, dental restorations and full dentures. This program was eliminated in 2009; and $206 million augmented mental health care services funding.
Many Public Health Programs Consolidated into Medi-Cal Managed Care Almost all Healthy Families Program (HFP) enrollees (approximately 880,000 children) have been transferred into Medi-Cal managed care. CAFP and many other health care stakeholders vehemently opposed this transition and raised concerns that health care services for some beneficiaries would be disrupted, which would be particularly damaging to enrollees with chronic or complex health conditions. In addition, we argued that a blanket transition would further exacerbate the existing access to care issues faced by MediCal enrollees. CAFP continues to monitor the transition and its effects, working to ensure continuity of care and the preservation of physician-patient relationships. For more information on the transition, including a provider Frequently Asked Questions (FAQ), on which CAFP provided guidance. The state also plans to move a large portion of individuals who are dually-eligible for Medicare and Medi-Cal into MediCal managed care as part of the Department of Health Care Services’ (DHCS) Coordinated Care Initiative. The program, now named “Cal MediConnect,” will be administered by Health Net, Molina Healthcare and WellPoint. The project has capped enrollment at 456,000 patients, including a maximum of 200,000 in Los Angeles County. Joining Los Angeles in the demonstration are Orange, Riverside, San Bernardino, San Diego, San Mateo, Alameda and Santa Clara counties. CAFP has raised concerns regarding patient protections during the transition next year and that the project is not meeting its legislative requirements to establish Patient Centered Medical Homes (PCMHs) as a fundamental component of the care coordination process. In response to these changes and the payment issues detailed above, CAFP created a Family Physician Medi-Cal Task Force. The goal of the Task Force is to ensure that patients do not get left behind or fall through the cracks as these changes are made. The Task Force also wants to provide a direct line of communication among legislators, administrators and physicians so quick corrective action can be taken, if necessary, as these new policy changes are implemented. In particular, the Task Force is focused on patient access to care, preserving provider-patient relationships and ensuring adequate payment structures 26
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for providing care to people with complex disabilities. The Task Force is composed of family physicians from counties throughout California: Sacramento, Los Angeles, Siskiyou, Contra Costa, Orange, Monterey, San Francisco, Nevada, Ventura and Fresno. Task Force members see a high percentage of Medi-Cal patients in different settings: county facilities, clinics, universities and private practice. California Is All-In for the ACA • California announced early on that it would be a full supporter of the Affordable Care Act (ACA) and took several actions to expedite some of its provisions. The Governor called for a legislative special session to “consider and act upon legislation necessary to implement the federal Patient Protection and Affordable Care Act,” including reform of California’s private health coverage, individual and small group markets regarding guaranteed issue of coverage, preexisting condition exclusions and rating restrictions; • The expansion of Medi-Cal eligibility, enrollment and retention; and • Options that allow low-cost health coverage to be provided to individuals who have income up to 200 percent of the Federal Poverty Level. There is debate as to whether this would mean creating a Basic Health Plan option or a Bridge Plan (a Medicaid managed care plan offered through the Exchange to low-income households on a limited enrollment basis). As a supporter of the ACA, CAFP supported special session legislation and provides frequent comment to legislators and their staff regarding the importance of reforming our health care system to one based on primary care, team-based care and patient access. California was also one of the first states to start developing its own Health Insurance Exchange, Covered California. Covered California offers a website where individuals, families and small businesses can shop for health insurance using apples-to-apples comparisons, similar to Travelocity or Expedia. Enrollment in health insurance programs through the website began on October 1, and coverage for those who enrolled by December 23, 2013 took effect on January 1, 2014. The next enrollment deadline was January 15 for coverage beginning February 1, but open enrollment continues until March 31. CAFP was awarded a grant from Covered California to help inform physicians and their staffs about health care coverage available to their patients as part of the ACA. The grant supports the development of educational programs for physicians and other health care providers and materials that inform patients about Covered California benefits. For more Covered California information on CAFP’s website: http:// www.familydocs.org/covered-california
CAFP’s Legislative Wins Below is a partial list of CAFP-supported bills that were signed by the Governor. The full list can be read here: http://www.familydocs. org/advocacy/priority-legislation Payment AAFP and CAFP scored a major win in the Affordable Care Act (ACA) with a provision that raises Medicaid payment rates for primary care services to the level of Medicare payment for services provided from 2013-2015. DHCS made its first interim payment to attested fee-for-service physicians on November 4 and the payment process to physicians in Medi-Cal managed care plans is expected to begin in January 2014. Prescription Drug Abuse and Monitoring SB 809 (DeSaulnier) raises money for the Controlled Substance Utilization Review and Evaluation System (CURES), which is used to monitor prescription drug use. The funding would come from a $6 annual fee on almost all licensed health care providers, wholesalers of dangerous drugs, clinics and pharmacies. Physicians are required to enroll in the system, but not yet mandated to use it.
Access to Care • SB 352 (Pavley) allows a physician-supervised care team member (physician assistant, nurse practitioner or nursemidwife) to supervise a medical assistant working as part of that team without requiring the physician to be onsite. The bill would allow this in all medical office settings, instead of only community clinics and free clinics, where it is currently permitted. • AB 1288 (V.M. Pérez) requires the California to develop a process to give priority review status to an applicant for a medical license who can demonstrate his or her intent to practice in a medically underserved area or treat a medically underserved population. ACA Implementation Four CAFP-supported Special Session bills were signed that help to implement the ACA. ABx1 1 (Pérez) and SBx1 1 (Hernandez) authorize the Medicaid eligibility expansion contained in the ACA. ABx1 2 (Pan) and SBx1 2 (Hernandez) prohibit health insurance companies from denying people coverage based on preexisting health care conditions and limit the factors that can be used to determine health insurance premiums to age, geography and family size.
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Help is at Your Fingertips!
Hundreds of Thousands of People Seek Health Care Coverage at Covered California January 1 marked the historic beginning of massive health care coverage for U.S. residents under the Affordable Care Act. California’s state health insurance exchange, Covered California, opened for business October 1 and has been one of the bestoperating exchanges nationwide. Between October 1 and November 30, nearly 432,000 applications covering 777,000 individuals were started. By the end of November, 179,000 applicants were deemed likely to qualify for Medi-Cal. The pace of Covered California signups continued to increase as the deadline neared. Between December 1 and 7, more than 144,000 applications – averaging 20,590 per day – were completed. More than 49,000 people selected plans, an average of 7,100 per day. Members of the public had until December 23 to enroll in coverage to start on January 1. Open enrollment continues, however, through March 31. Most California residents are required to have coverage by January 1 or pay a penalty with their 2014 tax filing in 2015. The California Academy of Family Physicians, with three partner organizations, is working under an $865,000 grant from Covered California to inform physicians and physician assistants (PAs) about the state health insurance exchange and to support your efforts to let patients know that new coverage options are available. We have launched a series of in-person and online trainings, a Covered California resource page on our website, www.familydocs.org/ covered-california and developed print materials for your use. (See box above.) Another important resource is a training video by CAFP President Mark Dressner, MD, outlining ways patients can access the exchange. For an excellent overview of Covered California, see the video here: http://www.familydocs.org/covered-california Remember, family physicians do not need to become insurance or health care marketplace experts – that’s not your role. The most important action you can take to help more people gain coverage is to let patients know they can find comprehensive information 28
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CAFP has created notepads and postcards to support physicians and their staff in letting patients know about Covered California (CC). Materials are available free of charge. Each of the 50 sheets in this notepad bears the same message, making these easy reminders to hand out to patients. The postcards provide the same information, encouraging patients to visit the website or call CC. These materials will be made available at all chapter meetings and the CAFP’s 2014 ASA. You can also help your patients by directing them to the Covered California website – www.coveredca.com. The website, available in English and Spanish, provides a wealth of information in step-by-step format, as well as the opportunity to enroll in coverage. By working their way through the website, users can determine (based on their income) whether they qualify for Medi-Cal, a private health plan with subsidies, or a private plan without subsidies. Patients are also welcome to call and receive information and assistance enrolling, free of charge. 1-800-300-1506. The website includes a library of resources you can download for your office – available in more than 12 languages! CAFP’s website also has tools, resources, up-to-date registration information, and links to live and online meetings! www.familydocs.org.
and enroll at the Covered California website or by phone. (See box above.) Please let your office staff members know too, as they also have contact with your patients who need coverage. CAFP staff and leaders will continue building information resources tailored to family physicians’ interests and need-to-know as health care reform rolls out.
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California Family Physician Winter 2014 29
Susan Hogeland, CAE
executIve vIce PresIdent’s Forum
Putting Patients First, to Infinity and Beyond Why do we want to designate 2014 as The Year of the Family Physician (YOTFP)? Because despite the bumps, pot holes, cave-ins and a few washouts on the highway to implementation of the Affordable Care Act (ACA), Americans need access to care and family physicians will be at the forefront of providing that care, hopefully using the Patient Centered Medical Home model to do so. Family physicians also have been at the forefront of advocating that insurance coverage be made available and affordable to all Americans. On the day I sat down to write this piece, two articles crossed my desk reinforcing AAFP’s and CAFP’s support for the ACA – one from AAFP’s “Smart Brief” digest and one from the New England Journal of Medicine (NEJM). “Smart Brief” excerpted a Commonwealth Fund survey finding 37 percent of US adults did not see a physician when they got sick and did not get recommended care or were not able to fill prescriptions due to cost. That compared with only four to six percent of adults in the United Kingdom and Sweden. The full article was published in Health Affairs. “Smart Brief” adds “[r] esearchers also found 23 percent of Americans had difficulty or were not able to pay their medical bills and 41 percent spent $1,000 or more on out-of-pocket costs, while far fewer adults in other affluent countries encountered similar issues.” New England Journal authors Michael Stillman, MD and Monalisa Tailor, MD wrote in “Dead Man Walking” about being “appalled” at a case in which an indigent patient spent his life savings on emergency room tests that discovered metastatic colon cancer after he had previously visited a primary care physician who charged $200 for the visit and told the patient he would need to have insurance to be adequately evaluated. Lacking resources and being ineligible for Medicaid in his state, the gentleman suffered intolerably until he was given his terminal diagnosis, at which time he termed himself a “dead man walking.” The authors cite a 2009 study that “revealed a direct correlation between lack of insurance and increased mortality and suggested that
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California Family Physician Winter 2014
nearly 45,000 American adults die each year because they have no medical coverage.” Opponents of the ACA say they do not want Americans to get “hooked” on another “entitlement program.” “Life, liberty and the pursuit of happiness” is an entitlement Americans are supposed to enjoy and the “life” part of that statement is hard for most to achieve in the absence of health insurance that provides adequate health care. That is why family physician organizations have supported the ACA, despite some of its flaws. Americans deserve access to a family physician and YOTFP highlights family physicians’ ability to do a lot of the heavy lifting as uptake and acceptance of the ACA increase. While advocating for better pay for primary care services and realignment of the payment system to acknowledge improved care models such as the Patient Centered Medical Home, AAFP and CAFP have never lost sight of patients. If I have learned anything after 22 years as Executive Vice President of CAFP, it is that our members put their patients first, and, I am confident, having met many cohorts of medical students interested in family medicine and residents in all years of training, that they will continue to do so – to infinity and beyond, as Buzz Lightyear would say. Serious mistakes have been made in the rollout of the ACA’s health benefit exchanges and it is time to fix those mistakes – it is well past time, in fact. Whether it is possible to fix all the mistakes in the current climate of “gotcha” politics is in doubt. CAFP is working to educate members and their office staffs about how they can assist patients and their family members in learning about health insurance coverage through Covered California, California’s health insurance exchange and we are working to address flaws identified to date in how family physicians and other clinicians may be affected by the health plans offered through Covered California.
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