Summer 2009 Volume 2009, Number 2
stiMuLus iMpACt hit stiMuLus provisions For physiCiAns
2009 FMA LegisLAtive report rACs Are bACk the pAper ChAse eMr system implementation
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suMMer 2009
Contents 2009 FMA LEGISLATIVE rEporT
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The 2009 Florida legislative session resulted in some significant and hard-won victories for the Florida Medical Association. Learn what the FMA did on your behalf at the state Capitol this year and how new laws will affect how you practice medicine.
rACs ArE BACK
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If you bill fee-for-service, make sure your office is in compliance with Medicare rules and is familiar with recovery audit contractor (rAC) Connolly Healthcare. In this article, learn the facts about rAC, the five levels of appeal, the most common reasons for overpayment and how you can be better prepared if you become a target of a rAC audit.
HIT STIMuLuS proVISIonS For pHySICIAnS
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Sweeping federal economic legislation means billions of dollars for Medicaid and Medicare incentive programs — plus aid for physicians who implement meaningful use of electronic health records. Find out what’s available, and for whom.
DECLArInG InDEpEnDEnCE
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relations between physicians and hospitals have been strained for years, and with health care reform on the way, are likely to become worse. As Congress considers health care reform, it is important for physicians to position themselves in a manner which will give them leverage in dealing with hospitals in their communities. Developing an independent medical staff at your hospital is critical in this process.
12 AMA PRESIDENT-ELECT CECIL B. WILSON, MD 36 THE PAPER CHASE: STRATEGIC PLANNING IS THE KEY TO SUCCESSFUL EMR IMPLEMENTATION 44 LIABILITY PERSPECTIVE: CURBSIDE CONSULTS 66 THE AGING OF THE BABY BOOMERS AND THE FUTURE OF PHYSICIAN PRACTICES: JOHN AGENS, MD 73 POLITICAL PROFILE: A Man on the Mission: Rep. Ron “Doc” Renuart 76 LIVES OF SERVICE, LEGACIES OF INSPIRATION
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prESIDEnT’S LETTEr ExECuTIVE VICE prESIDEnT’S LETTEr FMA ALLIAnCE prESIDEnT’S LETTEr EDITor’S LETTEr
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FlorIDA
meDICAl O
SSOCIAT A L I
mAgAzINe
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2009-2010
suMMer ’09
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board of governors Michael l. Patete, Md district e
ashley e. Booth, Md Young Physician section
Madelyn e. Butler, Md President-elect
nabil a. el sanadi, Md district F
Joel r. Judah, Md resident and Fellow section
Vincent a. degennaro, Md Vice President
stephan Baker, Md district g
courtney e. Bovee Medical student section
ralph J. nobo, Jr, Md secretary
silvio a. garcia, Md at large
ann M. anderson, rn FMa alliance
W. alan Harmon, Md Treasurer
andrew H. Borom, Md at large
Peggy Farmer Public Member
alan B. Pillersdorf, Md speaker
lisa a. cosgrove, Md Primary care specialties
Margaret eadington, Ms council of Medical society executives
david J. Becker, Md Vice speaker
linda s. cox, Md Medical specialties
stephen r. West, Md immediate Past President
alan s. routman, Md surgical specialties
John n. Katopodis, Md district a
Miguel a. Machado, Md council on legislation
eli n. lerner, Md district B
e. coy irvin, Md aMa delegation
david M. McKalip, Md district c
James H. rubenstein, Md FMa Pac
Harold l. greenberg, Md district d
M. Kamel H. elzawahry, Md specialty society section
E S TA B
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James B. dolan, Md President
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EDITorIAL STAFF Editor-in-ChiEf Karl M. altenburger, Md
Helping Physici
ana Viamonte ros, Md, MPH state surgeon general robert e. cline, Md state Board of Medicine
AssoCiAtE Editors Marilyn M. cox, Md Thomas l. Hicks, Md John M. Montgomery, Md MAnAging Editor lynne Takacs
PubliCAtion dEsign Michael calienes michaelc@transplant-1.com AdvErtising shawn Winship
Timothy J. stapleton executive Vice President to learn more about advertising in Florida Medical Magazine, contact shawn Winship at swinship @ medone.org, 1-800-762-0233, or visit www.fmaonline.org/rateCard.pdf
suMMer 2009 (VoluMe 2009, nuMBer 3) SSOCIAT
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copyright 2009 by Florida Medical association, inc. all rights reserved. Views expressed in this issue represent those of the individual authors and may not represent the views of the Florida Medical association, inc. The Florida Medical association, inc., does not represent the accuracy or reliability of any of the advertisers displayed in this publication and does not necessarily endorse any of the advertisers in this publication.
CA
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FLORIDA MEDICAL MAGAZINE is published four times a year (February, May, august and november) by the Florida Medical association, inc., located at 123 south adams street, Tallahassee, Fl, 32301-7719.
E S TA B L I S
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1
Helping Physicians Practice Medicine
Visit www.fmaonline.org for more information and updates or call 800.762.0233.
application to Mail at Periodicals Postage Prices is Pending at Tallahassee, Fl. PosTMasTer: send changes to: Florida Medical Magazine 123 south adams street Tallahassee, Fl 32301-7719
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FMA
09
suMMer ’09 t he ne x t life you s ave might threaten your very own.
Your pager vibrates. You set your knife
voice. That’s why we want you to become
and fork down on your plate. Your spouse
a member. Our physicians’ voices are the
knows. Your children know. Even your
inspiration behind many tools we use to
dog dashes to the door and wags his tail goodbye. Your body moves based on muscle memory. There’s hardly any
protect physicians and improve medicine in Florida. Tools like pay payment advocacy, continuing medical education, practice management assistance, and even expert help to ensure proper coding so
thinking involved. You’re on auto pilot. On your way to the hospital, you think about the delicate bal-
that payments for treatment are much less likely to be retracted.
ance of it all. Life and death. Family and profession. Yin and yang. This is the life you chose, and with good reason. You chose it because you wanted to help. You wanted to make a difference whenever and wherever you could. In times that require the most guided focus, the last thing that
I feel it is my duty to be involved with the FMA, and that every physician should feel as obligated. Strong membership gives us a louder and more effective voice. — Miguel A. Machado, M.D. Neurosurgeon, St. Augustine
should enter any doctor’s mind is the possibility of being sued,
Our Governmental Affairs Division represents you and your
of losing your license, of a
patients before the Florida Legislature. We develop pro-medicine
million other things that could
legislation geared toward creating a more friendly climate for
happen as a result of doing
doctors. We track hundreds of bills concerning important matters
the very thing you have been
like scope of practice and regulatory issues. We strive to lessen
trained to do.
the bureaucracy of medicine so doctors can spend more time
Malpractice suits have
with their patients. Quite simply, if it concerns your practice, it
become as commonplace as
concerns us. As a matter of fact, just this past year, the FMA
the common cold — a by-
helped push the very bill responsible for reducing the look back
product of treating patients.
period from 30 months to 12 — a victory that incited an audible
They threaten reputations,
sigh of relief from physicians statewide.
careers, families, and livelihoods. So where do we go from here? The Florida Medical Association provides some much needed
By adding your unique voice, experience, and perspective to the Florida Medical Association, we’ll be able to continue developing
advocacy and protection. It’s times like these when you need an
tools that are more
organization on your side that can take the industry’s pulse and
useful to you and our
provide actionable answers and solution-driven legislation. That’s
more than 19,000
us. That’s the FMA.
physician members.
We don’t have every solution. That’s why we need to hear your
Join today.
To learn more about the Florida Medical Association, call 800.762.0233, or visit www.fmaonline.org.
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StAyINg
FoCuSeD IN the FACe oF ChANge
PreSIDeNt’S letter
by James B. Dolan, MD, FMA President
oon sAturdAy, JuLy 25, 2009,
it was my privilege to take the presidential oath of office and become the 133rd president of the Florida Medical Association. that evening i made a promise that i would like to underscore today. during my term as president, i pledge to commit my full attention and effort to serving you, the physicians of Florida and this great organization. My vision throughout my term as president p is simple – i want to see the FMA continue its growth in numbers, prestige, and above all, in its capacity to meet its mission of “helping physicians practice Medicine.”
The FMa has had a long journey. However, when i reflect on where we began and the road that has led us to where we are today, i can say with certainty that i believe the FMa has never been stronger or more prepared to serve its members. With that said, i also believe no organization can maintain the status quo and remain successful. rather, it must stay focused on the path ahead, striving to achieve even greater heights. already, we are off to a great start. i am pleased to report we have the right executive Vice President in Mr. Timothy J. stapleton, the right FMa staff, the right Board of governors, the right committees and councils, and the right relationships with Florida’s county and specialty societies to do just that. Most importantly, we have you – a newly energized membership – to keep us focused in our pursuit of making Florida a friendlier place for you to practice medicine. staying focused is key. There are looming threats to our vocation, among which the erosion of our professional and
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clinical autonomy are foremost. The hospitals, JcaHo, insurers, regulators, and the federal government increasingly tell us how we should practice medicine. Yet, each of us has toiled a lifetime to gain, perfect, and maintain our clinical skills. Why should we yield the privilege and responsibility our profession brings to anyone but ourselves? Who else can have more consideration for our patients’ well being and our best interest other than physicians? among the many goals i would like the FMa to achieve this year is to help physicians regain their professional autonomy where it has been eroded and strengthen our autonomy where it still remains. To that end, i have appointed a Task Force on Medical staff autonomy, chaired by dr. ralph nobo, Jr., Md, and have charged them to draft a “Physicians’ Bill of rights.” How can you claim your rights have been abridged if they are not delineated? We will codify those rights, publish them,
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distribute them to all FM FMa members and beyond that ask the medical staffs to post them in physicians’ lounges, change rooms and mail rooms across Florida. That same task force also is charged with developing a model set of hospital staff medical by-laws that will protect the individual staff member, not the hospital. These will be disseminated to the medical staffs across the state and honed by the inevitable lawsuits to follow, creating a strong case law based document. Further, we will encourage every medical staff to adopt these by-laws and retain their own attorney, not the hospital’s. Beyond this primary charge, i will ask the task force to take a look at sham peer-review, bundling and any other mechanism whereby hospitals are manipulating their medical staffs to the detriment of individual staff members. To support those of you maligned or attacked unfairly by your hospital, we are putting together an FMa Member advocacy section based on the aMa advocacy section to defend physicians from manipulation by hospitals. While this is in its initial phase now, i look forward to reporting to you its progress in the months ahead. Your FMa has worked hand-in-glove with the aMa at the national level in legislative and regulatory advocacy. There have been times, inevitably though, that our focuses have not been completely aligned, and we have felt the need to provide additional advocacy on behalf of the physicians of Florida. i feel that this can no longer occur on an ad hoc basis and have formed a Task Force on national legislation, chaired by coy irvin, Md, to evaluate our current level of participation in advocacy at the national level and make recommendations for the future. earlier this year, i pledged to a large central Florida emergency Physician practice that i would not neglect the issue of specialty physician er coverage. each of us is painfully aware of this issue and the seeming lack of solutions for it. The Florida college of emergency Physicians has
formed a task force to examine this issue and has invited the Florida Hospital association and the FMa to participate. i have appointed our chair of the council on legislation, Miguel Machado, Md, to serve as the FMa’s representative on this important task force. Finally, it goes without saying that the strength of the House of Medicine is its members and their unity of purpose. The face of medicine in Florida is literally changing, and to the list of entities to which each of us feels loyalty, primarily our county and specialty society, we must add the cultural and ethnic medical societies. These are groups based on a shared origin or cultural experience, and they are growing in number. it is critical that just as the FMa strives to be relevant and important to our traditional constituencies, we welcome and include these groups. i began personally sharing this invitation with them during my term as FMa President-elect and will continue to do so in the coming year. These initiatives are in addition to the ongoing, day-today work of the association done by its Board of governors, councils and committees and staff. While a great deal of work lies ahead, including issues and challenges that for now remain unseen, you can rest assured that we are up to the task. Thank you again for this great honor. My wife, cheryl, and i look forward to seeing many of you personally during the upcoming year. Most of all, i look forward to standing before the FMa House of delegates in 2010 and reporting to you on a job well done. sincerely,
James B. Dolan, MD FMa President
lISteN to Dr. Dolan’s Presidential Address before the FMA House of Delegates at www.fmaonline.org/am2009/presentation
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releVANCe & VAlue: our CommItmeNt to you exeCutIVe VICe PreSIDeNt’S letter
by Timothy J. Stapleton
it is hArd to beLieve
that almost a year has passed since the Florida Medical Association (FMA) board of governors offered me the position of executive vice president. Much has changed since i joined the FMA over 12 years ago; however, one thing remains true. it is an honor and a privilege to serve this great organization and you, the physician.
over the past 12 months, the FMa has made great strides. our membership is at an all time high, while associations across our state and nation are experiencing a decrease in members. The FMa finished 2008 with over 19,000 members for the first time in its history, and i am proud to report we are on track to exceed that number this year. These numbers are indicative of several things; however, the message they convey the loudest is that the FMa is an organization that Florida physicians want to be a part of.
as our new President, Jim dolan, Md, stated during his speech at the FMa annual Meeting, “We are enjoying our current successes because today’s Florida Medical association is doing two very simple things well: number one, we are proving ourselves relevant to the physicians of Florida and, number two, we are providing a value in membership that exceeds the cost of joining.”
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We have also passed ground breaking managed care reform in Florida. For the second year in a row, the FMa passed significant legislation that has become a model for the nation. The assignment of benefits legislation that passed this year, as well as the managed care reform legislation passed in 2008, are among the most physicianfriendly pieces of legislation signed into law in any state over the past 20 years. simply put, the FMa is viewed with respect in Tallahassee, and our political clout at the state capitol has never been more valued.
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AS you kNow, ProVIDINg releVANCe AND VAlue IS AN oNgoINg ProCeSS. as the landscape of medicine in our state continues to change, we strive to stay ahead of the curve and address the issues that are important to you. To that end, i am pleased to announce that we have several programs and services on the horizon that are all centered on making it easier for you to practice medicine.
According to the American Health Lawyers Association’s membership rankings, we are now the largest healthcare law firm in the United States.
Here’s a sneak peak: in the coming months, you can look forward to a revamped FMa website that will include a “members only” section with fresh content and opportunities for you to interact with your colleagues. This new members only section of the website will include a “Knowledge center” that provides answers to frequently asked legal, regulatory, medical economic and practice management questions. The website will also include social networking features designed to bring the medical community in our state closer together. it is our intention to make the FMa’s website an indispensable tool for Florida’s physicians.
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Providing a platform for physicians to share ideas and interact has never been needed more than at this time in history. While it goes without saying, this is a critical time for physicians. in Washington, dc, proposals are being put forth that have the potential to dramatically change the health care delivery system in our country. The FMa will continue to be at the forefront of public policy issues as we advocate for proposals aimed at protecting the doctor/patient relationship and keeping government and insurance companies from intruding on the practice of medicine. as the debate over health care reform heats up in our nation’s capital, you can count on the FMa to keep you updated on the latest proposals being put forth by policy makers and to provide you with opportunities to make your voice heard.
IN C
We achieved this by delivering value and security to our clients every day.
Timothy J. Stapleton FMa executive Vice President
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.
Yes, these are truly exciting times to be a part of the FMa. no matter what challenges lay ahead, you can rest assured that the FMa will be standing right beside Florida physicians, walking lock step ahead in making Florida a friendlier place for physicians to practice medicine. Thank you for being a part of this important organization. i look forward to continuing to serve you in the months and years ahead.
www.kslaw.com/health
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FmA AllIANCe letter From the PreSIDeNt by Ann Anderson, RN
iF you hAd one word
to describe how you got to where you are today in your medical profession, sacrifice would be
an understatement. the hours logged during residency, moments lost with family, and money spent on student loans are just a few of the hardships that come with being a physician. Compound this issue with fighting for autonomy in the legislature, the practice of medicine can almost be unbearable.
We get it. in fact, we know it better than anyone else. all that you’ve been through and what you are currently experiencing just to practice medicine is the reason the FMa alliance (FMaa) was established. as the spouse of a physician, i have witnessed the overload and weariness brought on by the profession. i joined the FMaa to support my husband. i stay a member to empower the medical community. it is a goal of our strategic plan to be a continued partner with the Florida Medical association and promote physicianfriendly legislative issues. as the 20092010 FMa alliance President, i have every intention of meeting this goal. senate Bill 1122 was a hard-won battle for all those in the medical profession. The importance of this bill cannot be overstated. insurance companies now must honor a patient’s choice to assign their benefits to the physician providing the service, rather than routing the check through the patient. if anyone is good at leveraging relationships, it’s alliance members. during the 2009 legislative session, members from all over the state traveled to the capitol through the FMaasponsored program Mission: Tallahassee. This program increases visibility of the
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medical family by providing members an opportunity to speak with their legislator to discuss the important issues facing physicians and their patients in Florida. They also receive personal legislative training from FMa staff.
legislation, and tips on contacting respective legislators. The loop has been an influential tool through which members have supported, and ultimately assisted passing, important bills such as sB 1122.
This was not the first time the FMa alliance supported Florida physicians, nor will it be the last.
The historic “Yes on Three� bill in 2004 was heavily supported by the FMa alliance. This bill had been the subject of legislative debate for years, and the medical community was determined it would be passed into law in 2004. alliance members stood shoulder-to-shoulder with their physician spouses on the front steps of the capitol, rallying on behalf of this effort. Members never lost the drive to impress upon legislators and the public the importance of this bill. They never surrendered the cause, and pushed until it passed on the nov. 2, 2004 election ballot.
in 2002, the FMaa launched the legislative loop, an email update of current political events and action alerts. it provides members information on physician and health-related
The alliance’s advocacy of physician-friendly legislation has inspired local communities to take their involvement to the next level. The lee county Medical society
When the time came to have sB 1122 signed into law, FMa alliance members contacted gov. charlie crist, mailing him letters and calling his office, expressing the importance of this bill. They reached out to their communities and asked others to contact the governor. in continued support, members gave to the FMa special legislative Fund, which was pivotal in making physician voices heard.
alliance received the american Medical association alliance legislative education and awareness Promotion award twice for its programs on Bundled Md 1000 club Membership (2003) and leaP into the legislative challenge (2004), both geared to increase the number of medical families participating in the FMa Pac. seminole county Medical society alliance also received recognition for creating constitutional amendment Kits in 2004. We have a history of devoting our time, energies and efforts to what we believe in. and we believe in you and your profession. The purpose of alliance members is to support physicians, and what better way to do that than through organized medicine? ask your spouse today if he or she is a member of the FMa alliance. Their membership is your benefit. go to www.fmaalliance.org for information on FMa alliance membership, or call 800.762.0233.
the Council on Medical education & science congratulates the winners of the Florida Medical Association 2009 poster symposium at the FMA Annual Meeting. FIrSt PlACe
SeCoND PlACe
Dominic Maggio BS, University of Miami School of Medicine
Joshua Lenchus, DO, University of Miami Miller School of Medicine, Jackson Memorial Hospital
PoSter tItle: Identifying the Long-Term Role of i-NOS in Contusive Spinal Cord Injury Using a Transgenic Mouse Model
PoSter tItle: A New Paradigm in Medical Education: Reducing Complications through Standardized Training
Join us for the next Poster Symposium at the 2010 Annual Meeting, August 13-15th at Hilton Bonnet Creek, Orlando.
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From the eDItor by Karl M. Altenburger, MD
when the president w of our Florida Medical Association asked me to serve as editor of Florida Medical Magazine,
it was not possible to decline. in addition to the opportunity to serve, i very much appreciate the written word. Modern technology notwithstanding, elegant composition remains one of the joys of a civilized society. however, i confess that i accepted dr. dolan’s entreaty with some trepidation. dr. Marc yacht, the previous editor, helped guide this magazine to new, even award-winning heights. his will be difficult shoes to fill and we all owe him a great debt of gratitude. in addition, the professionalism of the FMA staff creates pressures of its own to perform; great expectations, indeed. i also welcome and look forward to serving with our two new Associate editors, dr. Marilyn Cox from the Capital Medical society and dr. John Montgomery from the duval County Medical society, and our veteran Associate editor, dr. tom hicks, also from Capital Medical society. All have been engaged, at many levels, in organized medicine, and they bring a wealth of experience to this publication.
This is an exciting time to be actively engaged in the affairs of this, the greatest profession. all of us have been called to care for our friends, neighbors, and communities. so much of what we do is invisible to public scrutiny and, therefore, too often unappreciated by the casual observer. our patients appreciate our efforts, however, as do our colleagues. even though storm clouds are fixed over the nation’s capitol, medical school applications are at an all-time high. new medical students remain eager and engaged. our professional obligation, then, is to ensure that these students will possess the tools necessary to continue the delivery of the world’s best health
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care. While not a perfect system – nothing constructed by man is – medicine’s calling always has been to continuously learn and improve, and we are dedicated to that ideal. in this issue of the Florida Medical Magazine, we welcome our new FMa President, dr. James B. dolan, and appreciate the many contributions of his predecessor, dr. steven r. West. Thank you both for your service. a review of the significant accomplishments of this past legislative session and the FMa’s ongoing work to help you practice medicine are highlighted. regulatory challenges are also discussed and important
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articles about how the Federal stimulus Package and rac will affect you are well worth your time. The liability implications of “curbside consults” and the importance of physicians retaining control of their hospital staff bylaws are included. The impact, insufficiently recognized, i believe, of the aging of our population on all medical and surgical
specialties is presented, and a number of physician servant leaders are profiled. one in particular is the american Medical association’s new Presidentelect and FMa Past President, cecil B. Wilson, Md. We are blessed that individuals with dr. Wilson’s experience are available to help us manage the crises and opportunities confronting us.
Finally, i would ask for your assistance in helping us identify topics of importance and interest to you. our mission — the FMa’s mission — is to Help You Practice Medicine. let us know how we are doing. all comments and suggestions are welcome and appreciated. send them directly to me at: editor@medone.org.
AboVe: Florida Medical Magazine veteran Associate Editor, Thomas Hicks, MD.
leFt to rIght: Florida Medical Magazine Associate Editors, John Montgomery, MD, and Marilyn Cox, MD, along with Karl M. Altenburger, MD, Editor-in-Chief.
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CeCIl b.wIlSoN, mD President-elect of the American medical Association
CeCiL b. wiLson, Md, Ce
an internist from winter park, was elected president-elect of the American Medical Association (AMA) in June 2009. he has been a member of the AMA board of trustees (bot) since 2002 and served as chair of the AMAAMA-bot from 2006 to 2007. dr. wilson also has been a member of the AMA house of ddelegates since 1992, and previously was elected to two terms as a member of the AMA Council on Constitution and bylaws, of which he also served as vice chair.
dr. Wilson has a distinguished record of service and leadership in organized medicine. He was president of the Florida Medical association (FMa) and chair of its board of governors and executive committee. in 2003, dr. Wilson was recognized by the FMa with its highest award, the certificate of Merit. He served as president of the orange county Medical society and on the medical staffs of the Winter Park Memorial Hospital and Florida Hospital Medical center in orlando. after receiving his bachelor’s degree in history and his doctorate from emory university, dr. Wilson interned at the u.s. naval Hospital, Portsmouth, Va., and completed his residency in internal medicine at the u.s. naval Hospital, san diego. He served as a navy flight surgeon, rising to the rank of commander. dr. Wilson has been in private practice of internal medicine in central Florida for more than 30 years. He is board-certified in internal medicine and a Master of the american college of Physicians (acP).
american society of internal Medicine (asiM) and was a member of the merger committee between acP and asiM, which resulted in the largest medical specialty society in the united states. at the state level, dr. Wilson has received the prestigious laureate award for service to internal medicine from the Florida chapter of the acP. in addition to his work within organized medicine, dr. Wilson is a board member of cola, a physician-run organization that accredits more than 8,000 physician office laboratories nationwide. He is also a past president of the Florida statewide Health council and past chair of the local Health council of east central Florida. dr. Wilson and his wife, Betty Jane, past president of the FMa alliance, have three children.
dr. Wilson’s service in organized medicine includes leadership in his specialty of internal medicine. He is a past chair of the acP Board of regents. He also served on the board of the
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FlorIDA meDICAl ASSoCIAtIoN
legISlAtIVe
rePort your rEquESTS For ASSISTAnCE delivered via resolutions acted on by the FMa House of delegates and by direct petitions to me, your council on legislation and the FMa leadership have been heard. over the past two years we have fought in Tallahassee, on your behalf, to make these a reality. What follows is a summary of our significant accomplishments this past legislative session.
The FMa’s mission to help you practice medicine requires strength and persistence. We will remain steadfast advocates for you and our patients. Work has already begun on next year’s legislative agenda. i look forward to your questions, comments and suggestions. Thank you for allowing me to serve you and our profession. sincerely,
Miguel A. Machado, MD FMA Council on Legislation Chair
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FmA SuPPorteD legISlAtIoN AssignMEnt of bEnEfits sb 1122 By senator don gaetz sb 855 By representative Marcelo llorente The sole purpose of sB 1122 is to require an insurance company to pay an out-of-network physician directly whenever the patient has assigned the right to payment to that physician. This bill was the FMa’s top priority, and despite the bill’s simplicity, generated a tremendous amount of opposition from Bluecross Blueshield and other organizations, which distorted the effects of the bill. all this bill does is require the insurance company to pay the physician directly. This bill does not change the current law on balance billing. This bill does not increase the amount that the managed care company has to pay. This bill does not increase a patient’s out-of-pocket costs. This bill does not adversely affect the managed care companies’ physician networks. in order to address the concerns of legislators over the bill’s alleged fiscal impact, the FMa agreed to allow the bill to sunset in 2012 if the office of Program Policy analysis and government accountability finds that the change in the law has caused Bluecross Blueshield to suffer a net loss of physicians from its PPo network, and as a direct result, has caused an increase in costs to the state group health plan. sB 1122 was passed overwhelmingly by both the House and senate and was signed into law by the governor on June 10, 2009. insurance companies began complying with this law on July 1, 2009.
ControllEd substAnCE dAtAbAsE / rEgulAtion of PAin CliniCs sb 462 By senator Mike Fasano hb 897 By representative Marcelo llorente at the urging of pain physician groups and others, the FMa for the first time made it a priority to pass legislation that would help combat the growing problem of prescription drug abuse. With the assistance of a broad coalition, the FMa was able to pass legislation that calls for the creation of an electronic database to track controlled substance prescriptions, and gives the Board of Medicine the authority to establish new regulations for pain clinics. a detailed summary follows. The bill requires the department of Health (doH), by dec. 1, 2010, to design and establish a comprehensive electronic system to monitor the prescribing and dispensing of certain controlled substances. The bill requires dispensers of certain controlled substances to report specified information to the
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doH for inclusion in the system. When the direct support organization authorized in the bill receives at least $20,000 in non-state monies or the state receives at least $20,000 in federal grants for the prescription drug monitoring program, the doH must adopt rules to implement the system. The rules must be adopted by the doH in consultation with the office of drug control and must address the reporting, accessing the database, evaluation, management, development, implementation, operation, security, and storage of information in the system.
data regarding the dispensing of each controlled substance must be submitted to the doH no more than 15 days after the date the drug was dispensed, by a procedure and in a format established by the doH, and must include minimum information specified in the bill. any person who knowingly fails to report the dispensing of a controlled substance commits a first-degree misdemeanor. The bill provides exemptions from the data-reporting requirements for controlled substances when specified acts of dispensing or administering occur for that specific act of dispensing or administration. The office of drug control, in coordination with the doH, is authorized to establish a direct-support organization to provide assistance, funding, and promotional support for activities authorized for the prescription drug monitoring program. The bill creates a 12-member Program implementation and oversight Task Force within the executive office of the governor to monitor the implementation and
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safeguarding of the electronic system established for the prescription drug monitoring program. The bill provides immunity from liability for prescribers and dispensers who in good faith receive and use information from the prescription drug monitoring program. a person may not recover damages against a prescriber or dispenser authorized to access information under the drug monitoring program for accessing or failing to access such information. The bill requires certain privately owned pain-management clinics to register with the department of Health by Jan. 4, 2010, unless otherwise exempt. The Boards of Medicine and osteopathic Medicine shall adopt rules setting forth standards of practice for physicians who practice in privately owned pain-management clinics that primarily engage in the treatment of pain by prescribing or dispensing controlled substance medications. This bill was passed by both the House and the senate and was signed into law by the governor on June 18, 2009. This legislation took effect on July 1, 2009.
A PubliC rECords EXEMPtion for thE PrEsCriPtion drug Monitoring ProgrAM sb 440 By senator Mike Fasano hb 937 By representative Marcelo llorente This bill is a companion to sB 462, which establishes a prescription drug monitoring program. This bill would provide that certain information pertaining to the program is exempt from the public record laws. This bill was passed unanimously by both the House and the senate and was signed into law by the governor on June 18, 2009. This legislation took effect on July 1, 2009.
hEAlth CArE CliniC EstAblishMEnt PErMit sb 1144 By senator durell Peaden hb 7095 By the Health care regulation Policy committee The legislature passed a bill during the 2008 legislative session that established the Health care clinic establishment Permit (Hcce). This permit was created in response to a declaratory opinion from the doH that group practices and other corporate entities could not purchase and own legend drugs. Those entities eligible to
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receive a permit are now able to purchase such medications. The problem was that the original law was drafted too narrowly and only a few types of legal entities were eligible for the permit. sB 1144 provides that any legal entity that provides health care or veterinary services may obtain an Hcce permit. This bill fixes the problem with the original permit system. While this is a needed fix for the Hcce permit system, the FMa sought to repeal the system in its entirety and simply allow group practices to purchase legend drugs without having to endure the cost and hassle of obtaining the Hcce permit. To this end, the FMa actively supported sB 574, which would have accomplished this objective while still providing accountability for the storage and handling of these medications. unfortunately, doH opposed this effort and only sB 1144 passed. This bill also makes a number of changes to the “pedigree paper” provisions of the Florida drug and cosmetic act. sB-1144 was passed unanimously by both the House and the senate and was signed into law by the governor on June 24, 2009. This legislation takes effect oct. 1, 2009.
dori slosbErg & KAtiE MArChEtti sAfEtY bElt lAW sb 344 By senator Thad altman hb 1 By representative rich glorioso This legislation, referred to as the “dori slosberg and Katie Marchetti safety Belt law,” amends existing safety belt laws by making it a primary offense not to wear a seatbelt. Previously, the police could stop and issue a citation to a driver not wearing a seat belt only if the driver committed another infraction. sB 344 passed the House and senate and was signed into law by the governor on May 6, 2009. This legislation became effective July 1, 2009.
floridA KidCArE ProgrAM sb 918 By senator nan rich This legislation makes several changes in the “Florida Kidcare Program.” Kidcare is Florida’s scHiP or cHiPra program that was established in 1998 as a combination of Medicaid expansions with a wrap-around delivery system serving children with special health care needs. The bill
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modifies eligibility determination by requiring family income to be verified electronically. The bill also removes administrative barriers to the program by decreasing the time that a child is disenrolled for nonpayment of premiums from 60 to 30 days and reducing the waiting period for Kidcare eligibility from 6 months to 60 days for families who have voluntarily canceled their employersponsored or private health insurance. The bill increases the number of “good cause� reasons that families can use to voluntarily cancel their health insurance coverage and be immediately eligible for Kidcare coverage without any waiting period. The estimated impact of these provisions totals $15.1 million, with $4.4 million coming from general revenue and $10.7 million from dedicated trust funds. sB 918 passed unanimously out of both the House and the senate and was signed into law by the governor on June 2, 2009. This legislation took effect on July 1, 2009.
sovErEign iMMunitY/EMErgEnCY hEAlth CArE ProvidErs sb 2662 By senator al lawson hb 1083 By representative ronald renuart This legislation would have mandated that any physician providing emergency care and services pursuant to obligations imposed by federal and state law would be
considered an agent of the state and thus immune from suit. unfortunately, neither the House nor senate bill was heard in any of their respective committees of reference this session.
CovErAgE for MEntAl And nErvous disordErs sb 354 By senator Victor crist hb 147 By representative ed Homan This legislation would have created a second category of mandated offering (by insurers) for mental health services and would have defined those mental health conditions that must be covered within the new mandated offering. such services would have generally included all diagnostic categories of mental health conditions listed in the most recent edition of the diagnostic and statistical Manual of Mental disorders and those listed in the mental and behavioral disorders section of the current international classification of diseases. The legislation would have required that such mental health benefits may not be more restrictive than the treatment limitations of other applicable diseases, illnesses, and medical conditions. sB 354 passed out of its first committee of reference but was not taken up further while its House companion never received a hearing in any of its respective committees of reference.
FmA oPPoSeD legISlAtIoN oPtoMEtrY sb 326 By senator charlie dean hb 507 By representative Juan zapata This bill would have allowed optometrists to prescribe oral medications, including schedule iii, iV and V controlled substances. current law limits optometrists to prescribing topical medications. The FMa actively opposed this scope of practice expansion, and sB 326 was defeated in the senate Health regulation committee on a 5-3 vote. HB 507 never received a hearing in the House.
ArnP PrEsCribing sb 426 By senator Mike Bennett hb 1259 By representative Juan zapata This bill would have allowed arnPs to prescribe controlled
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substances, which they cannot do at present under current law. The FMa actively opposed this scope of practice expansion. neither bill received a hearing in committee.
CArdiologY sErviCEs sb 1938 By senator lee constantine hb 1033 By representative ronald renuart This bill sought to create a statewide sTeMi care system by imposing a timeline for the establishment of eMs referral patterns and by mandating hospital care protocols. enforcement of these changes in sTeMi care were to be implemented by the Florida agency for Health care administration (aHca) and the doH in different regional emergency care areas. sB 1938 was defeated in the senate Health regulation committee. HB 1033 died on second reading on the House calendar.
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vACCinE sAfEtY ACt sb 200 By senator Mike Bennett hb 39 By representative Michael scionti This bill would have prohibited the sale, purchase, manufacture, delivery, importation, administration, and distribution of vaccines containing organic or inorganic mercury compounds in excess of certain amounts. The FMa opposed this legislation. different versions of this bill were amended into other bills, but neither this bill nor any bill containing the subject of this bill passed during the 2009 session.
hEAring intErPrEtErs sb 2084, By senator stephen Wise hb 1277 By representative Bill Heller This bill would have created regulation of interpreters for the deaf and hard of hearing and provided for the creation of a regulatory program to be located in the department of Business and Professional regulation (dBPr). The bill created the Board of interpreters for the deaf and Hard of Hearing within dBPr to consist of nine members appointed by the governor and confirmed by the senate. The bill would have created a regulatory scheme, provided definitions, scope of practice, employment guidelines, continuing education, accountability, rules, licensure, and
fees. according to the proponents, the bill created a system of regulation to safeguard the consumer. The bill provided for regulation of approximately 900 practitioners who currently perform the duties of an interpreter for the deaf and hard of hearing. in addition, it created licensure as an interpreter or transliterator and created categories of provisional license, temporary license, special limited license, deaf interpreters permit, registered permit, and temporary permit. exemptions were applied for worship services, religious ceremonies, emergencies, actions under the good samaritan act, actions while on a cruise ship, pro bono temporary services, and actions by interns and students. The bill would have prohibited a physician from paying a staff person who was qualified to interpret but not licensed. The bill also provided that a person who violated the provisions of the bill committed a misdemeanor of the first degree. The FMa has always kept a close watch on this legislation and been prepared to amend it to ensure that those who provide interpreting services without renumeration in a physician’s office would be exempt from the licensure requirement. Fortunately, neither the House nor the senate bills were scheduled for a hearing this session.
other heAlth CAre legISlAtIoN MEdiCAid frAud sb 1986 By senator don gaetz This is an omnibus bill that contains many different provisions aimed at combating health care fraud, abuse, and waste. The FMa was able to insert a provision into this bill late in the session that changed the selfreferral laws so that sleep medicine physicians are now able to refer their patients for sleep-related testing to a facility they own, without having to be physically present while the testing is taking place. The Board of Medicine had interpreted the law so as to require the physician to directly supervise all testing – an interpretation that would have put the majority of physician-owned sleep centers out of business. an in-depth discussion of the other provisions in this 160 page bill follows. The bill increases the Medicaid program’s authority to address fraud, particularly as it relates to home health services, in several ways:
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» requiring that home health services for Medicaid recipients be medically necessary and ordered by a physician via a written prescription that meets the specified requirements in law. » requiring all Medicaid recipients to receive information once a year on how to report criminal Medicaid fraud, the Medicaid Fraud control unit’s toll-free hotline number, and the reward program created in the bill. » requiring aHca to post a list of all Medicaid providers that have been sanctioned or terminated for cause from the Medicaid program on its website. » requiring aHca to use technology to address health care fraud. » requiring aHca to track Medicaid provider prescription and billing patterns and evaluate them against Medicaid
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medical necessity criteria and coverage limitation guidelines adopted by rule and include this information in the Medicaid Program integrity and Medicaid Fraud control unit’s joint annual report. » requiring the Medicaid Program integrity unit to take action against a provider that violates s. 409.913, F.s. (Previously, this authority was permissive.) » authorizing aHca to enroll a Medicaid provider located outside of Florida if the provider’s location is no more than 50 miles from the Florida state line or aHca determines a need for that provider type. » requiring all health care facilities licensed by aHca to provide their clients an aHca-written description of Medicaid fraud and the statewide toll-free telephone number for the central Medicaid fraud hotline. The bill designates Miami-dade county as a health care fraud crisis area and directs aHca to implement two pilot projects in Miami-dade county to prevent the overutilization of home health services and control, verify, and monitor the delivery of home health services in the Medicaid program. The bill also targets fraudulent actors by increasing licensing standards for physicians and other health care providers by: » requiring aHca to deny a license to any health care facility applicant, and doH to deny a license, certificate, or registration to any health care practitioner applicant, if the applicant or any controlling interest has been: » convicted of, or enters a plea of guilty or no contest to, a felony under ch. 409, 817, or 893, F.s., 21 u.s.c. ss. 801970, or 42 u.s.c. ss. 1395-1396, unless the sentence or any subsequent period of probation ended more than 15 years ago; » Terminated for cause from the Florida Medicaid Program, unless the applicant has been in good standing with the Florida Medicaid Program for the most recent five years; or » Terminated for cause from the Medicare program or another state Medicaid program, unless the applicant has been in good standing with a state Medicaid program for the most recent five years and the termination occurred at least 20 years prior to the date of the application. » requiring pharmacy permit applicants to be fingerprinted and pass a state and national criminal history records check.
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» authorizing aHca to deny, revoke, or suspend the license of a home health agency,and requiring aHca to impose a fine of $5,000 against a home health agency, that demonstrates a pattern of billing the Medicaid program for medically-unnecessary services. » increasing the requirements for applicants for licensure as home health agencies, home medical equipment providers, and health care clinics to include additional financial documentation and a $500,000 surety bond for nonimmigrant aliens. » Prohibiting aHca from renewing a home health agency license, if the applicant is located in a county that has at least one home health agency and the county has more than one home health agency per 5,000 persons, based on the most recent population estimates published by the legislature’s office of economic and demographic research, and the applicant or any controlling interest has been administratively sanctioned by aHca in the last two years for a specified list of violations. » creating a moratorium on new and change of ownership home health agency licenses in counties that meet certain criteria until July 1, 2010. The bill creates disincentives to commit Medicaid fraud by creating additional criminal felonies for committing health care fraud by: » creating a first- and second-degree felony for persons who commit Medicaid provider fraud. The new penalties increase in severity based on the amount of money stolen from the Medicaid program or the amount of money the provider attempted to steal. » requiring Medicaid providers convicted of Medicaid fraud to pay the state a fine equal to five times the amount of money stolen from the state or the total amount of money stolen from the Medicaid program, whichever is greater. » creating a third-degree felony for persons who apply for a home health agency, durable medical equipment, or clinic license and knowingly file information on the licensure application that is misleading or false. The bill decreases the financial surplus requirements for entities that contract with aHca on a prepaid basis, including Medicaid HMos, provider services networks, and prepaid mental health plans. The surplus requirements will be the same as for commercial HMos.
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The bill also directs aHca to develop a plan to implement a medical home pilot project that uses primary care case management enhanced by medical home networks to provide coordinated and cost-effective care that is reimbursed on a fee-for-service basis and to compare the performance of medical home networks with other existing Medicaid managed care models. The bill addresses Medicaid fraud and abuse and streamlines health facility regulation through aHca. The sections of the bill related to licensure reduce duplicative and unnecessary regulation by: » eliminating duplicative reporting, certain annual reports, an outdated pilot project, a multi-agency workgroup, registration of utilization review agents, quality-of-care monitors, provisions related to dining assistance which are addressed in federal law, and the requirement for a certificate of exemption for a clinical laboratory that performs only waived tests. » revising conditions that qualify as an adverse event that must be reported by nursing homes and assisted living facilities. abuse, neglect, or exploitation is no longer
classified as an adverse incident and is required to be reported immediately to the central abuse hotline and within five days to aHca. » eliminating the requirement for a nursing home to post the facility’s policy and procedures regarding a resident’s personal property and instead requiring the facility to provide a copy to employees and residents at admission and when revised. » revising provisions related to licensure and accreditation of clinics engaged in magnetic resonance imaging services. » Modifying uniform provisions for facilities licensed by aHca, including: » revising the definition of a change of ownership for facility licensure and for purposes of Medicaid enrollment; » eliminating the requirement for submission of a statement regarding a voluntary board member’s status;
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» requiring submission of information regarding a facility’s administrator and financial officer; » submission timeframes for licensure renewal applications and other applications and requests; » authorizing aHca to send documents electronically and to issue provisional licenses; » Providing for aHca’s communication of deficiencies, submission of corrective action plans by licensed facilities, and the classification of violations; and » Providing for emergency management planning and operations, including the designation of a safety liaison to serve as the primary contact for emergency operations, and inactive licenses. » designating additional disqualifying offenses for persons who work with facilities licensed by aHca. » deleting the requirement for aHca to publish certain information about nursing homes in printed form and to post information about nursing home deficiencies on the internet since this information duplicates data available
through a website maintained at the federal level. The bill also removes aHca from participating in the certification and regulation of 211 network providers, prohibits any provider licensed by aHca from knowingly discharging a patient or client to an unlicensed facility, and eliminates the requirement for aHca to require a medical assessment of a resident in an adult living facility if it appears that the resident needs care beyond the licensed capabilities of the facility. a specialty-licensed children’s hospital is authorized to provide certain cardiovascular services as a continuum-of-care for adults with congenital heart disease without obtaining additional licensure as a provider of adult cardiovascular services. The bill modifies the definitions of “standard reference compendium” pertaining to coverage for the use of drugs in treatment of cancer in insurance contracts to reflect the current authoritative compendia and “rural hospital” to extend the current designation as a rural hospital for certain hospitals until 2015. Finally, the bill modifies a provision passed in cs/cs/HB 873 to specify that the extension of a certificate of need only applies to certificates of need issued prior to april 1, 2009.
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sB 1986 was passed unanimously by both the House and the senate and was signed into law by the governor on June 24, 2009. This legislation took effect on July 1, 2009.
AutisM sPECtruM disordEr / vACCinAtion inforMEd ConsEnt / vACCinAtion sChEdulEs sb 242 By senator Jeremy ring hb 33 By representative Kevin ambler hb 89 By representative steve Precourt sB 242 as originally filed required physicians to refer a child to an appropriate specialist for screening for autism spectrum disorder if the parent or guardian expressed any concern about the child being autistic. The original language of the bill was deleted and new language was inserted that changed the informed consent requirements for childhood vaccines. The bill was later amended again, this time to add language that prohibited more than trace amounts of mercury in certain vaccines and allowed parents to choose an alternate vaccination schedule for children. The bill died in the Policy and steering committee on Ways and Means. HB 33 died in the PreK-12 Policy committee. HB 89 died in the insurance, Business & Financial affairs Policy committee.
PrACtiCE of PhArMACY sb 1868 By senator durell Peaden hb 433 By representative Ken roberson This legislation originally contained a provision that would allow a pharmacist to make therapeutic substitutions, in certain instances, for medications prescribed by a physician in a nursing home setting. The FMa was successful in first amending this provision, then finally having it removed from the bill entirely. sB 1868, as passed, amends the law relating to health insurance coverage for use of drugs in the treatment of cancer to update the definition of “standard reference compendium” to mean an authoritative compendium identified by the secretary of the united states department of Health and Human services and recognized by the centers for Medicare and Medicaid services. The bill revises requirements for written prescriptions for medicinal drugs to delete a requirement that the quantity of the drug prescribed be in both textual and numerical formats and that the prescription be dated with the month written out in textual letters. The bill requires a written prescription for a controlled substance to have the quantity of the drug prescribed in both textual and numerical formats and be dated with the abbreviated month written on the face of the
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prescription. if the prescriber of a controlled substance is unavailable to verify a prescription, the pharmacist may dispense the drug under specified circumstances. The pharmacist may dispense a controlled substance but may require the person to whom it is dispensed to provide valid photographic identification. The bill authorizes the pharmacist to dispense a controlled substance for a prescription that does not include the quantity or date written out in textual format without verification of the quantity or date written on the prescription. The pharmacist may do so only if the pharmacy previously dispensed another prescription for the person to whom the prescription was written. The bill transfers a provision that exempts pharmacists from ch. 468, part XiV, F.s., relating to orthotics, prosthetics, and pedorthics, to ch. 465, F.s., the Florida Pharmacy act. sB 1868 was passed unanimously by both the House and the senate and was signed into law by the governor on June 18, 2009. This legislation took effect July 1, 2009.
PhYsiCiAn AssistAnts/Co-signAturEs on ChArts sb 720 By senator durell Peaden hb 249 By representative Jimmy Patronis This legislation removes the statutory requirement that supervising physicians review and cosign charts and medical records of a physician assistant under the physician’s supervision. Prior to this legislation, a supervising physician was required by law to review, sign, and date all documentation by a physician assistant in medical charts within 30 days. While this legislation does eliminate the requirement by law that supervising physicians review and co-sign a Pa’s charts within 30 days, it does not change the ability of the supervising physician to require such review and co-signature within their practice protocols with their Pas. The bill also prohibits a medical physician from holding himself or herself out as a board-certified specialist in dermatology unless the agency that recognizes the specialty is reviewed and reauthorized by the Board of Medicine every three years. after receiving a great deal of correspondence from FMa members in support of this legislation, the FMa Board of governors voted not to oppose this legislation. sB 720 passed the House and senate unanimously and has been signed into law by the governor on June 16, 2009. This legislation took effect July 1, 2009.
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health care practitioner contracts with the PlHso, as a condition of contract continuation or renewal. The bill authorizes health care practitioners to meet their service obligations over the biennial licensure period, rather than annually, in order to be eligible for the benefits available to health care providers who volunteer their services under the access to Health care act. Practitioners who volunteer 160 hours of service over two years and provide the necessary documentation to doH are eligible for a waiver of their biennial licensure renewal fee and credit for up to 25 percent of their continuing education credits. retired health care practitioners must volunteer 800 hours over the biennium. HB 185 was passed unanimously by both the House and the senate and was signed into law by the governor on May 20, 2009. This legislation took effect on July 1, 2009.
ProfEssionAl liAbilitY ClAiMs sb 2252 By senator carey Baker hb 511 By representative Marlene o’Toole This legislation makes changes to the reporting requirements imposed on malpractice insurance companies, risk retention groups, commercial self-insurance funds, etc., regarding resolved personal injury claims. sB 2252 was passed unanimously by both the House and senate and was signed into law by the governor on June 16, 2009. This legislation took effect July 1, 2009.
frAud And AbusE in stAtE fundEd ProgrAMs ACCEss to hEAlth CArE hb 185 By representative Matt Hudson sb 702 By senator don gaetz This legislation adds a representative from the dental community to the Florida Healthy Kids corporation board of directors. The member will be appointed by the governor from three candidates who are nominated by the Florida dental association. The bill creates two new provider contract prohibitions for prepaid limited health service organization (PlHso) contracts entered into on or after July 1, 2009. contracts between a PlHso and a provider of limited health services may not contain provisions that prohibit or restrict the provider from contracting with other PlHsos. The bill also prohibits PlHsos from requiring providers to accept the terms of other
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sb 2658 By senator carey Baker This legislation increases the requirements for applicants for licensure as home health agencies, home medical equipment providers, and health care clinics to include additional financial documentation and a $500,000 surety bond for nonimmigrant aliens. The bill creates a moratorium on new and change of ownership home health agency licenses in counties that meet certain criteria until July 1, 2010. The bill also creates new third-degree felony offenses for certain violations relating to home health agencies, home medical equipment providers, and health care clinics. The bill amends the Florida False claims act to make it more difficult to award attorney’s fees to a False claims act defendant by specifying that, if the defendant is the prevailing party in a False claims act case, the court may award attorney’s fees if the court finds that the action was
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clearly frivolous, clearly vexatious, or brought primarily for the purposes of harassment. The bill specifies that the amendment to the Florida False claims act applies to any pending or future action on or after July 1, 2009. The bill also designates Miami-dade county as a health care fraud crisis area.
physician to practice medicine in Florida without sitting for or passing a licensure examination; however, these physicians may only practice in conjunction with a full-time faculty position at an accredited medical school and its affiliated clinical facilities or teaching hospitals. HB 387 passed both the House and the senate and was signed into law by the governor on June 1, 2009. This legislation took effect July 1, 2009.
sB 2658 passed both the House and the senate and was signed into law by the governor on June 16, 2009. This legislation took effect July 1, 2009.
ArnPs / CliniCAl lAborAtoriEs
MEdiCAl fACultY CErtifiCAtEs
sb 408 By senator Mike Fasano hb 53 By representative luis garcia
sb 1136 By senator dan gelber hb 387 By representative david rivera This legislation increases the number of allowed renewed medical faculty certificates from 15 to 30 for the following Florida medical schools: university of Miami; Florida international university; university of central Florida; university of south Florida; university of Florida; and Florida state university. in addition, this legislation increases the number of medical faculty certificates that may be issued to the faculty at the Mayo Medical school at the Mayo clinic in Jacksonville. a medical faculty certificate allows such a
This legislation adds arnPs to the list of providers from whom clinical laboratories are mandated to accept specimens. section 483.181, Florida statutes, governs the operation of clinical laboratories that accept human specimens, such as blood and urine, for analysis. currently, clinical laboratories must accept specimens from allopathic or osteopathic physicians, physician assistants, dentists, naturopaths, podiatrists, and chiropractors. There is no requirement, however, that the laboratories accept specimens from tests ordered by arnPs who are already permitted to order such tests.
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sB 408 passed the House and senate unanimously and was signed into law by the governor on June 10, 2009. This legislation took effect July 1, 2009.
nursing ProgrAMs sb 2284 By senator Mike Haridopolos hb 1209 By representative denise grimsley This legislation revises section 464.019, Florida statutes, streamlining the application process for new programs for the prelicensure education of both professional and practical nurses. HB 1209 codifies the standards for nursing programs into law and removes the Board of nursing’s authority to adopt rules for the approval of nursing programs. The bill also establishes a timeframe within which the Board of nursing must approve or deny a nursing program’s application based on a set of criteria (approval or denial must be made within 90 days). HB 1209 passed the House and the senate unanimously and was signed into law by the governor on June 11, 2009. This legislation took effect July 1, 2009.
floridA PAtiEnt sAfEtY CorPorAtion hb 7023 By House governmental affairs Policy committee sb 1896 By senate Health regulation committee This legislation repeals provisions of law creating the Florida Patient safety corporation (FPsc), the public records exemption and confidentiality provisions for patient safety data or other records held by the FPsc, and the public meetings exemption for portions of meetings held by the FPsc during which confidential and exempt information is discussed. Florida’s open government sunset review act requires the Florida legislature to reevaluate public record and public meeting exemption laws five years after their enactment. should the legislature fail to reenact the exemption, the law is automatically repealed on oct. 2 of the fifth year. When this law was initially enacted, the legislature had appropriated funds for the program, however, they did not for Fiscal Year 2008-2009. in Jan. 2009, the Board of directors of the Florida Patient safety corporation voted to disband the corporation, citing a lack of funding and lack of FPsc activities.
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HB 7023 passed the House and senate unanimously and was signed into law by the governor on May 28, 2009. This legislation took effect immediately upon becoming law.
CliniCAl CounsEling And PsYChothErAPY sErviCEs sb 498 By senator carey Baker hb 109 By representative leonard Bembry This legislation provides that there is no liability and no cause of action against a licensed clinical social worker, marriage and family therapist, or mental health counselor when such licensee makes a disclosure of otherwise confidential communications regarding a patient or client to the potential victim, appropriate family member, law enforcement or other appropriate authorities. in order to obtain the waiver of liability, the licensee must make a clinical judgment that there is a clear and immediate probability of physical harm to the patient or client, to other individuals, or to society, and the licensee may only communicate the information to the potential victim, appropriate family member, or law enforcement, or other appropriate authorities. HB 109 passed both the House and the senate and was signed into law by the governor on June 1, 2009. This legislation took effect July 1, 2009.
MEdiCArE suPPlEMEnt PoliCiEs sb 1022 By senator Thad altman hb 675 By representative ritch Workman This legislation, known as the “alonzo Mourning access to care act,” requires insurers issuing Medicare supplement policies in Florida to offer the opportunity to enroll in a Medicare supplemental policy to individuals under 65 years of age and eligible for Medicare by reason of a disability or end-stage renal disease.
funding. The bill also defines terms related to electronic health records and the exchange of health information and requires aHca to develop a universal patient authorization form for the use or release of a patient’s identifiable health record and provides immunity for the release of this record in reliance on information provided on the form. additionally, it sets forth criteria for the emergency release of an identifiable health record and permits clinical laboratories to disclose a patient’s test results, without the patient’s consent, to a health care practitioner who did not order the test but who is involved in the care of the patient. This bill was passed unanimously by both the House and the senate and was signed into law by the governor on June 16, 2009. This legislation took effect immediately upon becoming law.
floridA KidCArE ProgrAM hb 807 By representative gwendolyn clarke-reed sb 338 By senator Frederica Wilson This legislation directs the office of Program Policy analysis and government accountability to perform a study of the effectiveness of the outreach efforts of the Florida Kidcare Program for uninsured children. if the report finds deficiencies in the outreach process, the report shall provide options for correcting those deficiencies and include the projected cost of implementation. HB 807 was passed unanimously by both the House and the senate and was signed into law by the governor on June 18, 2009. This legislation took effect June 18, 2009.
HB 675 passed the House and senate unanimously and was signed into law by the governor on June 10, 2009. This legislation takes effect oct. 1, 2009.
floridA ElECtroniC hEAlth rECords EXChAngE ACt sb 162 By senator Jeremy ring This legislation creates the “Florida electronic Health records exchange act.” it provides for definitions of terms related to electronic health records and the exchange of health information and provides for a loan program to assist physicians in obtaining and implementing electronic health records systems pending receipt of federal stimulus
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iF you biLL Fee-For-serviCe,
get ready for the rAC. the tax relief and health Care Act of 2006 created a permanent, nationwide recovery audit program to detect and correct past improper payments and authorized the Centers for Medicare and Medicaid services (CMs) to hire contractors and pay them on a contingency basis. the recovery audit contractor (rAC) for region C, which includes Florida is Connolly healthcare.
connolly began data mining in Florida on March 1 of this year. To date, connolly has concentrated on hospital claims, and physician offices probably will not see any demand letters until late summer or early fall. Between now and then, you should educate your office and prepare. conduct an internal assessment to determine if you are in compliance with Medicare rules. if you are in doubt or have questions, consider hiring an outside entity to review a sample of your records/claims for evaluation. identify and communicate to your staff corrective actions that should be taken. limit unnecessary hardship and appeals by training your office coding staff and providing the most current reference materials. Make sure everyone in your office knows the name connolly Healthcare. demand letters will come from connolly and not from cMs. These letters may request
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medical records or a refund of an overpayment. occasionally, but not often, the letter may be to inform you that you will be receiving funds because of an underpayment. it is important that these letters be processed right away in order to receive any funds and protect any appeal rights that you may have. do not risk having a demand letter thrown away because the office staff did not recognize the sender. learn from your experience. look at any overpayments you may have received in the past. likewise, examine any claims that have been denied. This will give you guidance on where to concentrate training efforts. Pay particular attention to the four main reasons for overpayments discovered during the pilot rac program on page 30.
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look at other audit subjects on the cMs website at www. cms.hhs.gov/rac. The office of the inspector general (oig) at www.oig.hhs.gov/reports.html and the comprehensive error rate Testing (cerT) reports found at www.cms.hhs.gov/cert also will contain information
regarding improper payments. as new audit issues are developed, they will be posted to the rac website at www.connollyhealthcare.com/rac. all new audit subjects or targets must be reviewed and approved by cMs before the rac can undertake any (continued next page)
Appealing a Medicare recovery Audit Contractor (rac) overpayment: understanding the Appeals Process if you have received a letter from a Medicare recovery audit contractor (rac) requesting overpayment(s) and you believe it is incorrect, you may appeal. it is important to understand key deadlines in the appeals process. outlined below are the steps you should take.
1
THE
5 LEVELS oF AppEAL
2
3
recoupment(s) halted: if physician appeals within 30 days of receiving letter requesting overpayment. interest Accrues: With or without an appeal 31 days from date physician receives overpayment letter, unless full repayment is made before this time. Max time to file initial Appeal: 120 days.
CAll
if you receive an overpayment letter, call your rac within 15 days from the date you receive it to discuss the overpayment and send any evidence to counter an offset. notE: calling your rac does not constitute a formal appeal.
APPEAl
if you continue to believe the request for overpayment is unjustified, you must file an appeal. if you do so within 30 days of receipt of the overpayment letter, you will avoid a Medicare recoupment action. notE: interest begins to accrue 31 days from the receipt of the overpayment letter regardless of whether an appeal is filed. no interest accrues if repayment is made within 30 days.
1st level Appeal
You have 120 days to file the first appeal which is referred to as a “redetermination.” redeterminations are conducted by carriers or Medicare administrative contractors (Mac). if the overpayment is upheld at the redetermination level, you have 180 days 10 appeal to the 2nd level. notE: While you have 120 days to file the first appeal, you can only avoid a Medicare recoupment action if you do so within 30 days.
2 level Appeal
second level appeals are referred to as “reconsiderations.” reconsiderations are conducted by Qualified independent contractors (Qics). if the overpayment is upheld at the reconsideration level, you have 60 days 10 appeal 10 the 3rd level.
3rd level Appeal
at the third level of appeal, an administrative law Judge (alJ) will review your case. if the overpayment is upheld, you have 60 days to appeal to the 4th level.
4th level Appeal
at the fourth level of appeal, an HHs department appeals Board will review your case. if the overpayment is upheld you have 60 days to appeal to the 5th level.
5th level Appeal
at the fifth level of appeal a Federal district court will review your case.
nd
rEfund ovErPAYMEnt
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fAst fACts:
if your appeal is upheld and making a repayment in full represents a hardship, ask your rac if you qualify for an extended repayment plan. notE: interest is waived if an overpayment has been returned within 30 days of final determination.
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reasons for overpayments Collected by Error type 42% 32% 9% 17%
widespread examination. This oversight step was put in place by cMs in response to problems reported during the pilot project. a rac will submit a proposed issue to cMs and cMs then has 60 days to review the issue and decide on its value and appropriateness. if approved, the “new issue” will be posted to the rac website and the rac can begin region-wide review. racs use two types of review when auditing claims. automated reviews occur when routine data mining clearly shows an improper payment for which additional documentation is not necessary. a good example of an automated review overpayment would be a duplicate claim. The other kind of review, usually referred to as “complex,” occurs when the improper payment is not apparent from a review of the claims data. cMs recently announced that complex reviews for drg validation, as well as coding errors, will begin in september of this year. in october, the start of fiscal year 2010, complex reviews for durable medical necessity will begin, followed by reviews for such medical necessity. The medical necessity claims are likely to produce the most stress, as it is easy to disagree over such matters. More specific information about the nature of these various audits will be posted on the cMs and rac websites in the near future. There is nothing magic about the way a rac conducts an audit. it does not have any tools, tricks or resources that you don’t. The racs must follow all applicable Medicare policies and guidelines when reviewing claims, including national coverage determinations (ncds) and local coverage determinations (lcds), and they use the same reference and coding materials that are available to all physician practices. unlike other fiscal intermediaries, carriers, and Medicare administrative contractors (Macs), racs do not develop their own billing and coding guidelines. in addition, each rac must employ certified coders, nurses, and therapists, and must have a physician cMd. These changes from previous audit practices, in addition to advance notice of the review target, should help practices avoid excessive demands.
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incorrect coding Medically unnecessary no/insufficient documentation other
racs are also limited to a three-year “look back” period, and will not be able to review any claims paid prior to oct. 1, 2007. The number of medical records they can request is limited based on the number of physicians in the practice. also, if the rac loses at any level of appeal they must return any contingency fees received. Be prepared to respond to a rac request. use the connolly form to provide it with the precise address and name of the person in your office to contact when requesting medical records or overpayment refunds. That person should be responsible for responding to requests and making sure the medical record requested was received by the rac, and keeping track of the timeline for appeal purposes. record receipts will be posted on the rac website after Jan. 1, 2010, but it will be necessary to call prior to that date. if medical records are requested, follow the guidelines provided by connolly. remember that imaged records on a cd/dVd will be accepted by connolly and are cheaper to ship and less likely to be lost or separated. Know the recoupment and appeal rules in the event you receive a demand letter. cash flow will be disrupted if you do not act in a timely manner when dealing with correspondence from the rac. review and understand the appeal process, including the different timelines. racs, unlike other auditors, offer an opportunity to discuss improper payment determination outside the normal appeal process, but you should be careful not to confuse this discussion period with the appeals process. remember that the time runs on calendar, not business, days. Keep cMs and rac contact information handy. The region c rac, connolly Healthcare, can be reached at 1-866-360-2507 and on the web at www.connollyhealthcare.com/rac and racinfo@connollyhealthcare.com. Finally, remember that the FMa can help. contact linda McMullen (lmcmullen@medone. org), the FMa’s director of Medical economics, susan Franz (sfranz@medone.org), Medical economics specialist, or leslie Barber (lbarber@medone.org), coding specialist, with questions or requests for information.
www.fmaonline.org
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Provider Medical record (Mr) SubMiSSionS are due 45 days from the date of the medical record request letter. They may be sent as:
PAPEr MEdiCAl rECords: include the original or copy of the medical record request letter from the rac. if possible, highlight claims on the letter identifying the medical records attached.
Cd/dvd MEdiCAl rECords: Prior to an ongoing submission of medical records via a cd/dVd, a provider will have to perform a successful test of transferring medical records with connolly Healthcare. a successful test will be contingent on the below specifications being met:
F o r M AT
SuBMISSIon
» scanned image resolution must be 300 dpi and in black and white.
» images are to be sent via cd or dVd in a tamper-proof package.
» image format must be in either .TiFF or .PdF format.
» cd or dVd should follow the following naming convention for easy communication, tracking , and reconciling purposes: <Provider id>_<sent date in MM-dd-YYYY format>_<number of images>.
» one image per medical record, i.e., multiple-page image file. For example, a 200 page medical record will be one file. » The image file name must be the requested claim number. » For example, if the claim number 123456 is requested, the filename would be 123456. pdf or 123456.tif. » copy of our medical record request letter. » The following metadata (excel file or tab delimited text file) must be included with the image submission: » requested claim number » Begin date of service » end date of service » Patient name (first and last name)
» For security purposes, it is strongly suggested that all images sent should be encrypted and password protected. » if medical images are encrypted through Winzip, a separate email to the Mr address located at (www. connollyhealthcare.com) should be sent to connolly with the password needed to unzip the files referencing: <Provider id>_<sent date in MM-dd-YYYY format>_<number of images>. » if medical images are encrypted using PgP, public and private keys to decrypted image files must be established prior to shipment.
ACKnowLEDGEMEnT » once connolly receives the cd or dVd, it will be processed and a fax and/or email will be sent to the provider’s medical record contact person (identified on the request for contact information Form) with the following information: » cd/dVd name » received date » Processed date » status: accepted/rejected » reason for rejection: file count mismatch; page count mis-match; missing metadata file » The whole cd/dVd will be rejected if it fails validation. » it is strongly suggested that images sent on cd/dVd should be sent via trackable carriers (Fedex, uPs, dHl, registered usPs mail, etc.)
» Patient doB » Patient Hic number » Patent account/control number » Medical record number » Provider name (full name) » Provider number » Provider nPi » number of pages or the file size of the image submitted for acknowledgement purposes » Total number of medical records on the cd/dVd » There should be one entry per image in the metadata file.
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www.fmaonline.org
8/17/09 5:16:51 PM
Good News About Bad Accounts Low Cost Collection Service Now Available To FMA Members
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thANk you For SuPPortINg Sb 1122 The following individuals and organizations generously supported the FMAâ&#x20AC;&#x2122;s campaign to see Senate Bill 1122 signed into law. The passage of SB 1122 is a strong step in managed care reform in Florida. SB 1122 will help thousands of physicians not
These generous contributions made it possible for physicians to stand toe-to-toe with the insurance industry and come out victorious.
Thank you for your contribution to this campaign and for supporting the Florida Medical Association. Seeing SB 1122 signed into law is proof positive of the difference we can make when we unite to speak with one voice.
$2,500 or MorE
$500 to $999
Samuel A. Joseph, Jr., MD
American College of Surgeons, Florida Chapter
Andrew H. Borom, MD
Michael D. Kohen, MD
Khai Sheng Chang, MD
Alexander N. Lenard, MD
Panama City Surgery Center
Vincent A. DeGennaro, MD
Thomas K. Leonard, MD
James B. Dolan, MD
John C. Long, Jr., MD
H. Frank Farmer, Jr., MD, PhD
Nicholas J. Manzari, Jr., MD
Pamela Gail Freeman, MD
Peter Alan Marzek, MD
W. Alan Harmon, MD
Charles B. McIntosh, MD
Hillsborough County Medical Association
Hasan Murshed, MD
Indian River County Medical Society
Elliott C. Raby, MD
Kevin K. Lee, MD
Roger Rousseau, MD
Carl W. Lentz, MD
Gerold L. Schiebler, MD
Eli N. Lerner, MD
Craig R. Sweet, MD
Florida Orthopedic Society, Inc.
Marion County Medical Society
Victoria L. Torralba, MD
Ronald F. Giffler, MD
Cheri Oâ&#x20AC;&#x2122;Mailia
Ricardo E. Bornacelli-Vergara, MD
Scott S. Gordon, MD
Orange County Medical Society
Jack J. Wazen, MD
Hal M. Jacobson, MD
Juan Sanchez-Humala, MD
$1,000 to $2,400 Karl M. Altenburger, MD David J. Becker, MD Lora L. Brown, MD Robert E. Cline, MD Dade County Medical Association Florida Academy of Physician Assistants American College of Cardiology, Florida Chapter
John Katopodis, MD Ramesh T. Kumar, MD Lee County Medical Society Miguel A. Machado, MD David M. McKalip, MD Steven P. Rosenberg, MD Troy M. Tippett, MD Daniel W. Welch, MD Steven R. West, MD
34
only receive the payment they deserve, but also save time and money on collections.
Florida Medical Magazine suMMer 2009
Mag_2009_Summer.indd 34
$100 to $499
Christopher S. Newell, MD
uP to $100 Edward R. Annis, MD
Ann Anderson
Daniel S. Bendetowicz, MD
P. David Deleeuw, MD
Ayman A. Daouk, MD
Alfred C. Emmel, II, MD
Catherine Harrison-Balestra, MD
M. Felix Freshwater, MD Lawrence S. Halperin, MD
A sPECiAl thAnKs Also to
Christopher R. Hancock, MD
the Capital Medical Society,
Kaukwok F. Ho, MD
Tallahassee Memorial HealthCare and
Edward S. Homan, Jr., MD
Capital Regional Medical Center for
William H. Hood, MD
showing their support of SB 1122 by
Karl H.P. Horsten, Jr., MD
printing an open letter to the governor
Jose D. Jimenez, MD
in the Tallahassee Democrat.
www.fmaonline.org
8/17/09 5:16:53 PM
goV. CrISt SIgNS SeNAte bIll 1122.
A huge VICtory For FlorIDA’S ’S PAtIeNtS AND PhySICIANS. Senate Bill 1122 will improve access to care and honor a patient’s choice to assign his or her benefits to his or her physician directly, saving patients and physicians both time and money. Before this bill was passed, if a patient went out-of-network to see a physician, some insurance companies chose not to honor the patient’s request to send the payment to the physician and instead sent the
or call 800.762.0233.
check directly to the patient. While routing the payment through the DA ME DI
ORI
E S TA B L I S
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Mag_2009_Summer.indd 35
IO
FL
spent on direct patient care.
SSOCIAT
.
access and costing physicians time and resources they could have
LA
IN C
was driving up the cost of health care, imposing hidden fees, limiting
CA
N,
patient may have appeared to be a minor inconvenience, this practice
4
into law that will improve the efficiency of health care in Florida.
SB 1122 is a great victory for the patients and physicians of Florida. It is also just one more way the Florida Medical Association is fulfilling its mission to help you practice medicine. For more information, visit www.patientsoverprofits.com
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On June 10, 2009, Gov. Crist signed an important piece of legislation
HE
D
1
Helping Physicians Practice Medicine Florida Medical Magazine suMMer 2009
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8/17/09 5:16:56 PM
the PAPer
ChASe: thoughtFul PlANNINg
by R. David Evans
IS the key to emr
Investing in an EHR system
SyStem ImPlemeNtAtIoN
provides long-term savings by promoting patient access, saving physicians time in non-clinical related work, increasing billing accuracy, reducing transcription costs, eliminating paper and reproduction costs, potentially reducing staffing ratio, and converting chart storage rooms into additional office space.
Mag_2009_Summer.indd 36
8/17/09 5:16:59 PM
president bArACk obAMA
stated that, “it simply
doesn’t make sense that patients in the 21st century are still filling out forms with pens on papers that have to be stored away somewhere. As newt gingrich has rightly pointed out, we do a better job tracking a Fedex package in this country than we do tracking a patient’s health records.” Clearly, the obama administration and other advocacy groups are promoting and incentivizing the widespread use of electronic health records (ehr), also referred to as electronic medical records (eMr)1. the dream of a paperless health record system that reduces medical error and promotes overall
cost efficiency is attractive to any health care provider, but the task and cost of implementing such a system many times causes a nightmare. how should a physician begin implementing an electronic health record system?
e h r I m Ple m e N tAt I o N CoS t The average cost of an eHr system can be between $30,000 and $50,000 per physician with maintenance costs ranging anywhere from $3,000 to $15,000 annually.2 other external costs may include paying workers overtime throughout the training process, adding additional interface software to meet specialized needs, and purchasing new hardware for the office. although these costs may seem unworkable for many physicians, investing in an eHr system provides long-term savings by promoting patient access, saving physicians time in non-clinical related work, increasing billing accuracy, reducing transcription costs, eliminating paper and reproduction costs, potentially reducing staffing ratio, and converting chart storage rooms into additional office space. Maxwell iT, a health information technology (HiT) consulting firm, suggests building a five-year preliminary budget for purchasing an eHr system. using a five-year budget should allow most offices to realize full savings potential and determine at which point the practice breaks even on its investment. also, Medicare service providers who implement an eHr system within the next two years will receive a fiveyear incentive package, which will greatly affect any budgetary planning. Budgets should include both direct costs associated with purchasing hardware and software as well as indirect costs such as integration fees, iT support, and lost staff productivity during the transition period. Cr e At I N g A N o FFI Ce tA Sk Fo r Ce Many physicians are overwhelmed with various decisions in evaluating, choosing, and implementing an eHr system. even more, physicians are not the only office employees who will
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Mag_2009_Summer.indd 37
use and benefit from an electronic system. nurse practitioners, office managers, schedulers, and billing officers all will be affected by a new eHr system. Physician practices should appoint one person to be in charge of organizing eHr information, evaluating vendor options, and reporting which eHr option best serves the practice. different office employees may be suited to investigate and evaluate a certain aspect of eHr implementation. For example, a billing officer would be equipped to review whether a particular system design uses compliant evaluation and management (e/M) coding procedures. SelF-ASSeSSmeNt teChNIque in order to determine specific eHr needs, physicians should spend initial time gathering information and creating a workflow analysis. gathering information on the daily, weekly, and monthly tasks of each worker throughout the office will enable physicians to create a master list of office needs. additionally, all offices should evaluate their technicalreadiness and identify whether there is adequate high speed internet, hard drive and system backups, and Pcs for d ifferent workstations. offices should prioritize their specific needs. By prioritizing what office functions are more important, vendors are better able to discern which software pack is best for the office. different considerations may include viewing patient information, building electronic charts, 1 Remarks by the President at the Annual Conference of the American Medical Association. http://www.whitehouse.gov/the_press_office/Remarks-by-thePresident-to-the-Annual-Conference-of-the-American-Medical-Association. 2 American Medical Association. Selecting Health IT. http://www.ama-assn.org/ ama/pub/physician-resources/solutions-managing-your-practice/healthinformation-technology/putting-hit-practice/selecting-hit/self-assessment.shtml
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compiling patient demographics, interactions with internal billing and management software, searching capabilities, billing and coding requirements, e-prescribing, and standardized disease management for patient groups. in compiling this information, physician offices should create a list of questions for each potential vendor. Before spending time with an onsite visit from the vendor, a request for Proposal worksheet should be sent to each potential vendor, questioning whether that company’s software will adequately meet the office’s specific needs. a request for Proposal (rFP) should avoid “yes” and “no” questions and instead ask for details concerning the office’s individual workflow factors. a comprehensive questionnaire for potential vendors should include inquiries into the company’s background, the functional requirements of the software system, the technical requirements of the software system, any recommended implementation plan, and the company’s iT support options. Throughout the eHr implementation process, physicians should set deadlines for both employees and vendors in order to prevent indefinite stalling. a reasonable 30-day deadline should be set for companies to return any rFP. once the rFPs have been returned, physicians can narrow their software choices to approximately three candidates and extend invitations to these companies to demonstrate their respective software programs. any software demonstrations should be tailored to the office’s particular specialty and the individual needs articulated in the original rFP. FINAl VeNDor SeleCtIoN once full software demonstrations are complete, offices should further evaluate the software company’s overall financial stability and conduct a feature/price comparison for each software package. The financial stability of a potential eHr company is imperative. Physicians will need continuing technical support and may require additional software features after the initial implementation process. as with most
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technology, eHr system capabilities will continue to progress, and a software company’s financial stability provides assurance that new compatible software additions will be available. Physicians can compare final vendor options with a side-by-side spreadsheet listing the practice’s specialty specific requirements along with their related costs. For example, if the physician requires certain test results in a laboratory interface, then the feature price comparison chart should list whether the vendor supported this feature, if the feature was properly demonstrated, and any additional costs for the feature. Physicians should consider which of the final software packages are user friendly. offices may consider whether input from Pdas or wireless tablet Pcs are supported and easily integrated, and whether specialty specific templates are readable and reviewable. Physicians should not only consider whether screen appearances are functional, but also whether data is easily transferable in the event that the office switches to a separate eHr vendor. evaluating the cost and time requirements of implementation, training, and technical support will many times draw important distinctions between different eHr options. other areas of interest may include, potential upgrades, physician-patient communication capabilities, and whether physicians can gain remote access to the program. Ve N D o r Ce r tIFI C AtI o N since the passage of the american recovery and reinvestment act (arra), the vision of health information exchange quickly is approaching reality. as more physicians implement electronic systems, an overall standard must be developed to allow one physician’s program to read information from another program. arra calls for the national coordinator of Health information Technology to corroborate with the national institute of standards and Technology to formulate or recognize programs for the voluntary certification of health information technology. The certification commission for Healthcare information Technology (ccHiT) currently certifies eHr software based on certain HiT criteria. The commission focuses on privacy considerations, functionality, and interoperability of each software option. By browsing through the list of ccHiT certified vendors, physicians can begin to identify which vendors already have been recognized as reliable and functional. as a result of the timelines incorporated into arra, ccHiT has implemented three different levels of software certification in order to make certification more accessible. a panel within ccHiT, including at least one practicing physician, will review the electronic system under different clinical scenarios. For example, ccHiT will evaluate the
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of m Co m or ve an e re ag th d ed an on ca 90 re % pl an s1 I have type 2 diabetes. This is…
Model is for illustrative purposes only.
Indications and usage Levemir ® is indicated for once- or twicedaily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Important safety information Levemir ® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients. Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir ® . As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir ® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment. Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Levemir ® should not be
diluted or mixed with any other insulin preparations. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir ® from other intermediate or long-acting insulin preparations. The dose of Levemir ® may need to be adjusted in patients with renal or hepatic impairment. Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3% to 4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation. *Whether these observed differences represent true differences in the effects of Levemir®, NPH insulin, and insulin glargine is not known, since these trials were not blinded and the protocols (eg, diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences in weight has not been established.
For your patients with type 2 diabetes,
start once-daily Levemir® Levemir® helps patients with diabetes achieve their A1C goal.2,3 s HOUR ACTION AT A ONCE DAILY DOSE s 0ROVIDES CONSISTENT INSULIN ABSORPTION and action, day after day s ,ESS WEIGHT GAIN8* To access complimentary e-learning programs, visit novomedlink.com/Levemir References: 1. Data on file. Novo Nordisk Inc, Princeton, NJ. 2. Meneghini LF, Rosenberg KH, Koenen C, Meriläinen MJ, Lüddeke H-J. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007;9(3):418-427. 3. Hermansen K, Davies M, Derezinski T, Ravn GM, Clauson P, Home P, for the Levemir Treat-to-Target Study Group. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006;29(6):1269-1274. 4. Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab. 2007;9(3):290-299. 5. Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006;28(10):1569-1581. 6. Danne T, Endahl L, Haahr H, et al. Lower within-subject variability in pharmacokinetic profiles of insulin detemir in comparison to insulin glargine in children and adolescents with type 1 diabetes. Presented at: 43rd Annual Meeting of the European Association for the Study of Diabetes; September 17-21, 2007; Amsterdam, Netherlands. Abstract 0189. 7. Heise T, Nosek L, Rønn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes. 2004;53(6):1614-1620. 8. Data on file. NDA21-536. Novo Nordisk Inc, Princeton, NJ.
Please see brief summary of Prescribing Information on adjacent page. FlexPen® and Levemir ® are registered trademarks of Novo Nordisk A/S. © 2008 Novo Nordisk Inc. 133236-R2
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November 2008
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Rx ONLY BRIEF SUMMARY. Please see package insert for prescribing information. INDICATIONS AND USAGE LEVEMIR is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. CONTRAINDICATIONS LEVEMIR is contraindicated in patients hypersensitive to insulin detemir or one of its excipients. WARNINGS Hypoglycemia is the most common adverse effect of insulin therapy, including LEVEMIR. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. LEVEMIR is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal, human), or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted. PRECAUTIONS General Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. The first symptoms of hyperglycemia usually occur gradually over a period of hours or days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased urination, thirst and loss of appetite as well as acetone breath. Untreated hyperglycemic events are potentially fatal. LEVEMIR is not intended for intravenous or intramuscular administration. The prolonged duration of activity of insulin detemir is dependent on injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. Absorption after intramuscular administration is both faster and more extensive than absorption after subcutaneous administration. LEVEMIR should not be diluted or mixed with any other insulin preparations (see PRECAUTIONS, Mixing of Insulins). Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Lipodystrophy and hypersensitivity are among potential clinical adverse effects associated with the use of all insulins. As with all insulin preparations, the time course of LEVEMIR action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Hypoglycemia As with all insulin preparations, hypoglycemic reactions may be associated with the administration of LEVEMIR. Hypoglycemia is the most common adverse effect of insulins. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see PRECAUTIONS, Drug Interactions). Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patients’ awareness of hypoglycemia.
indicated that insulin detemir and human insulin had similar effects regarding embryotoxicity and teratogenicity.
In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.
Nursing mothers It is unknown whether LEVEMIR is excreted in significant amounts in human milk. For this reason, caution should be exercised when LEVEMIR is administered to a nursing mother. Patients with diabetes who are lactating may require adjustments in insulin dose, meal plan, or both.
Systemic allergy: Generalized allergy to insulin, which is less common but potentially more serious, may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening. Intercurrent Conditions Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or other stresses. Information for Patients LEVEMIR must only be used if the solution appears clear and colorless with no visible particles. Patients should be informed about potential risks and advantages of LEVEMIR therapy, including the possible side effects. Patients should be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo- and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dosage, instruction for use of injection devices and proper storage of insulin. Patients should be informed that frequent, patientperformed blood glucose measurements are needed to achieve effective glycemic control to avoid both hyperglycemia and hypoglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, or skipped meals. Refer patients to the LEVEMIR “Patient Information” circular for additional information. As with all patients who have diabetes, the ability to concentrate and/or react may be impaired as a result of hypoglycemia or hyperglycemia. Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy (see PRECAUTIONS, Pregnancy). Laboratory Tests As with all insulin therapy, the therapeutic response to LEVEMIR should be monitored by periodic blood glucose tests. Periodic measurement of HbA1c is recommended for the monitoring of long-term glycemic control. Drug Interactions A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring. The following are examples of substances that may reduce the blood-glucose-lowering effect of insulin: corticosteroids, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives). The following are examples of substances that may increase the blood-glucose-lowering effect of insulin and susceptibility to hypoglycemia: oral antidiabetic drugs, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of hypoglycemia may be reduced or absent. The results of in-vitro and in-vivo protein binding studies demonstrate that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound drugs. Mixing of Insulins If LEVEMIR is mixed with other insulin preparations, the profile of action of one or both individual components may change. Mixing LEVEMIR with insulin aspart, a rapid acting insulin analog, resulted in about 40% reduction in AUC(0-2h) and Cmax for insulin aspart compared to separate injections when the ratio of insulin aspart to LEVEMIR was less than 50%.
The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen or timing of dosing is changed. In patients being switched from other intermediate or long-acting insulin preparations to once- or twice-daily LEVEMIR, dosages can be prescribed on a unit-to-unit basis; however, as with all insulin preparations, dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia.
LEVEMIR should NOT be mixed or diluted with any other insulin preparations.
Renal Impairment As with other insulins, the requirements for LEVEMIR may need to be adjusted in patients with renal impairment.
Pregnancy: Teratogenic Effects: Pregnancy Category C In a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times the recommended human dose, based on plasma Area Under the Curve (AUC) ratio). Doses of 150 and 300 nmol/kg/day produced numbers of litters with visceral anomalies. Doses up to 900 nmol/kg/day (approximately 135 times the recommended human dose based on AUC ratio) were given to rabbits during organogenesis. Drug-dose related increases in the incidence of fetuses with gall bladder abnormalities such as small, bilobed, bifurcated and missing gall bladders were observed at a dose of 900 nmol/kg/day. The rat and rabbit embryofetal development studies that included concurrent human insulin control groups
Hepatic Impairment As with other insulins, the requirements for LEVEMIR may need to be adjusted in patients with hepatic impairment. Injection Site and Allergic Reactions As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy may include redness, pain, itching, hives, swelling, and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few
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weeks. On rare occasions, injection site reactions may require discontinuation of LEVEMIR.
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Carcinogenicity, Mutagenicity, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed. Insulin detemir tested negative for genotoxic potential in the in-vitro reverse mutation study in bacteria, human peripheral blood lymphocyte chromosome aberration test, and the in-vivo mouse micronucleus test.
Pediatric use In a controlled clinical study, HbA1c concentrations and rates of hypoglycemia were similar among patients treated with LEVEMIR and patients treated with NPH human insulin. Geriatric use Of the total number of subjects in intermediate and long-term clinical studies of LEVEMIR, 85 (type 1 studies) and 363 (type 2 studies) were 65 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly. ADVERSE REACTIONS Adverse events commonly associated with human insulin therapy include the following: Body as Whole: allergic reactions (see PRECAUTIONS, Allergy). Skin and Appendages: lipodystrophy, pruritus, rash. Mild injection site reactions occurred more frequently with LEVEMIR than with NPH human insulin and usually resolved in a few days to a few weeks (see PRECAUTIONS, Allergy). Other: Hypoglycemia: (see WARNINGS and PRECAUTIONS). In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, the incidence of severe hypoglycemia with LEVEMIR was comparable to the incidence with NPH, and, as expected, greater overall in patients with type 1 diabetes (Table 4). Weight gain: In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, LEVEMIR was associated with somewhat less weight gain than NPH (Table 4). Whether these observed differences represent true differences in the effects of LEVEMIR and NPH insulin is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established. Table 4:
Safety Information on Clinical Studies Weight (kg)
Type 1 Study A Study C Study D Pediatric Type 2 Study E Study F
Hypoglycemia (events/subject/month)
Treatment
# of subjects
Baseline
End of treatment
Major*
Minor**
LEVEMIR NPH LEVEMIR NPH LEVEMIR NPH
N=276 N=133 N=492 N=257 N=232 N=115
75.0 75.7 76.5 76.1 N/A N/A
75.1 76.4 76.3 76.5 N/A N/A
0.045 0.035 0.029 0.027 0.076 0.083
2.184 3.063 2.397 2.564 2.677 3.203
LEVEMIR NPH LEVEMIR NPH
N=237 N=239 N=195 N=200
82.7 82.4 81.8 79.6
83.7 85.2 82.3 80.9
0.001 0.006 0.003 0.006
0.306 0.595 0.193 0.235
* Major = requires assistance of another individual because of neurologic impairment ** Minor = plasma glucose <56 mg/dl, subject able to deal with the episode him/herself
OVERDOSAGE Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. More detailed information is available on request. Rx only Date of issue: October 19, 2005 Manufactured for Novo Nordisk Inc., Princeton, NJ 08540 Manufactured by Novo Nordisk A/S, 2880 Bagsvaerd, Denmark www.novonordisk-us.com Levemir® and Novo Nordisk® are trademarks of Novo Nordisk A/S.
© 2006 Novo Nordisk Inc.
130128R
May 2006
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programs’ functionality for a well child primary care check up reviewing factors such as correctly identifying patient and parent, documenting and tracking immunization history, providing guidelines for prevention and wellness care, monitoring potential adverse drug reactions, and generating quality improvement reports. S m A ll Pr AC t I Ce I m Ple m e N tAt I o N While around 57 percent of physician practices with 50 or more physicians have implemented an eHr system, only 13 percent of small or solo practices have implemented an eHr system. even with the Medicare incentive package, many small physician practices will experience difficulty in funding the upfront costs of an eHr system. in fact, the Medicare incentive payments do not reach physician coffers until the eHr system is integrated and the physician demonstrates meaningful use of the software. u.s. rep. Kathy dahlkember recently stated, “ultimately small and solo health practitioners are small businesses. similar to small business everywhere, one of their biggest challenges is accessing affordable capital.” rep. dahlkember, chairwoman of the subcommittee on regulations and Healthcare in the House committee on small Business, recently proposed a new bill seeking to guarantee loans for health information technology. Hr 3014, the small Business Health information Technology Financing act, seeks to amend the small Business act to allow loans of up to $350,000 to any single qualified eligible physician. currently, the legislation calls for the appropriation of $10 billion for loans directed only toward medical practitioners to acquire computer hardware, software, and related technology that supports meaningful eHr use requirements. This summer, Florida adopted the electronic Health record system adoption loan program as part of the Florida electronic Health records exchange act. The loan program calls for the deposit of certain eligible public and private donations into a grants and donations Trust Fund. The trust fund is appropriated specifically for certified health record technology, and the agency for Health care administration (aHca) will promulgate standard terms and conditions for use of funds within the loan program. ANother PhySICIAN’S exPerIeNCe While investigating different eHr options, physicians should consult with peers who have implemented a similar eHr system. specifically, contacting practice groups from the same specialty allows offices to view a particular vendor’s eHr system in action and determine the electronic needs for a particular practice area. not only will other offices provide helpful information about a software company, but they will
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identify shortfalls in their own implementation process that can be easily corrected or avoided. dr. Michael Wasylik (left), chairman of the FMa’s Managed care committee, recently completed full eHr integration throughout his office. “i love my eMr system, but i certainly experienced some difficulties throughout the process,” said dr. Wasylik, a orthopedic surgeon in solo practice in Tampa. dr. Wasylik chose the same eHr vendor that developed his practice management software, giving him the ability to integrate both systems and consult only one organization for technical assistance. although dr. Wasylik touts the advantages of his eHr system, he spoke frankly about some of the roadblocks he experienced on his path to implementation. Primarily, he experienced poor initial onsite training and a crippling bureaucratic corporate structure that was not amenable to problem-solving or physician assistance. dr. Wasylik explained, “i was surprised at how poor the training was for my eMr system. although i contracted for 70 hours of training, initially i felt as though i was getting nowhere. i experienced problems adapting and changing templates and when i tried to contact my eMr company, it was extremely difficult to reach them, and many times they did not return my phone calls.” dr. Wasylik went on to explain that once he was connected with a local company trainer who was proficient in the software, the office was trained at a basic level with simply 14 hours of training. “The key is being able to use a local trainer, someone that you can call when you have a problem, someone that knows your office set-up and is able to work with everyone in the office,” said dr. Wasylik. The ability to access general help and technical support is imperative throughout the implementation process. inquiring into a vendor’s training program should be an important part of any eHr evaluation. dr. Wasylik said, “at first, i was unaware that my eMr vendor offered training modules over the internet; now this resource has become a helpful tool.” Physicians should establish a clear understanding of their training needs and expectations up front. if the office experiences problems with training and template set-up, dr.
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protective of the ongoing care of my patients, and the ability to quickly pull up the information our physical therapist has put into a patient’s eMr increases my ability to oversee the patient’s care.”
Wasylik suggested finding someone within the company to talk to and tell them you are having serious problems. explain that legal action is something you would like to avoid, but that the office needs to have sufficient access to training. one technique that eased the transition for dr. Wasylik was a slow and evolving implementation plan. instead of going paperless for all patients at the same time, he gradually began to increase his use of eMrs for certain patients. “at first, i would only use my eMr system for two of the patients i saw in a given day,” explained dr. Wasylik. “after a week or so of this slow start, i had my office use the eMr system for all my knee patients. after some time getting comfortable with this, we would move on to use the eMr system for my hip patients, and so on. This slow incremental progression truly allowed my staff and i to become acquainted with the software without having to reduce the number of patients we saw through the office.” in regards to cost savings, dr. Wasylik’s office removed almost all office transcription costs. Physicians can simply add a short dictation note within the electronic record for any issue that is not easily documentable on the electronic system, or simply type in the information themselves. either way, transcription costs in many instances can be removed completely. even more, some physicians may be able to downsize their office after the eMr system is fully integrated. For example, dr. Wasylik’s office was able to permanently reduce his office staff size after one employee left the company. Besides decreased overhead expenses, dr. Wasylik is now able to quickly evaluate what medical action has taken place with his patients. as part of his orthopedic clinic, dr. Wasylik provides physical therapy services, and his eMr system allows him to track the progress and course of action for each of his patients. dr. Wasylik said, “i am interested in and
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ultimately, inquiring physicians can gain valuable information from other offices that already have implemented an eHr system. For example, dr. Wasylik said, “if i had it to do all over again, i would set up multiple workstations throughout the office instead of using the mobile tablet Pc option. Multiple workstations seem to be much more user friendly.” if you are beginning the process of evaluating software vendors and would like to be connected to other Florida physicians who have completed the process, the Florida Medical association will provide additional resources and connect physicians together for a more complete view of eHr implementation. legAl ISSueS oN the horIzoN The advantages of eHrs are advocated by our country’s political leaders, and they have been realized by practices throughout Florida. despite this push to implement eHrs, however, physicians and other risk management officials have recognized many problems related to accuracy and predictability. Mark Twain was instructional on the advent of electronic medical records when he wrote, “Be careful about reading health books. You may die of a misprint.” Many skeptics are concerned about the dangers of data integrity, quality of care, and malpractice protection. although software vendors usually promise enhanced protection from malpractice allegations because of detailed electronic records, physicians should thoroughly evaluate and recognize when a patient’s record has been adjusted unintentionally because of technological mishaps. new liability issues may include data loss or destruction, inappropriate corrections to medical records, inaccurate data entry, and unauthorized access and errors during the eHr transition period. Furthermore, many eHr systems allow copying almost identical information into a very large number of medical records. clearly, potential legal allegations exist if certain tests and observations are documented electronically, but were actually overlooked during a physical examination. Many physicians are concerned that certain eHr systems do not include error proofing technologies that recognize clear errors in the medical record. requiring physicians to conduct quality patient care while simultaneously double-checking for electronic malfunctions can prove disenchanting for patients and the overall system. To reduce liability concerns, physicians must ensure that their eHr company is committed to
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Mark Twain was instructional on the advent of electronic medical records when he wrote, “Be careful about reading health books. You may die of a misprint.” perfecting quality assurance and effectively training the office on safe and compliant eHr use. in a similar vein, many physicians have integrated their evaluation and management (e/M) coding system with their electronic medical records system. some government audits have uncovered that many systems have allowed, or even facilitated, the submission of non-compliant or fraudulent claims for e/M services. dr. Wasylik explained that, “Many eMr salespersons state that because you will be better able to document your patient’s visit, you will be able to upcode and charge more per office visit.” despite this promise, dr. Wasylik has warned fellow physicians that, “auditing companies require both medical necessity and medical documentation, and medical necessityFLMedical will always8-09 come before documentation in regards to billing accuracy.” Many eHr systems have failed to implement compliant e/M documentation and coding, which has lead to an increase in the percentage of physician claims submitted with level four and level five codes. in a recent study, compliance experts evaluated four small physician practices during the course of an audit to determine whether they had inaccurately billed for certain services. Throughout the audit, the government reviewed between 20 and 100 electronic charts for each physician and determined that the percentage of charts failing ranged from 20 to 95 percent per physician. The auditors concluded that inaccurate e/M claims were a direct result of using an eHr system in accord with e/M coding, and because of these errors, the physician practices were sanctioned between $50,000 and $175,000. Because these coding failures ultimately will lead to heightened government scrutiny, audits, and eventual sanctions,
physicians must insist that their vendors eliminate noncompliant documentation and implement effective software tools that are usable and efficient. Furthermore, certification programs that evaluate different vendor options should provide meaningful protection to both physicians and patients. even though there are serious legal issues surrounding the use and implementation of eHrs, proper training will allow physician offices to fully reap the benefits of an electronic system while cutting back on potential liability and fraud allegations. careful and concerted implementation procedures should allow physicians to successfully improve their daily practice of medicine. R. David Evans graduated from Wake Forest University and completed his Political Science honors thesis on health care, focusing on the political and legal impacts of America’s pharmaceutical companies. During that time, David interned under Sen. Mel Martinez, R- Fla., as an appointed member of the Stennis Congressional Leadership Program. Currently, David is a second year law student at the University of Florida Levin College of Law. In the summer of 2009, David clerked with the Florida Medical Association. 6/12/09
8:14 AM
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lIAbIlIty PerSPeCtIVe:
CurbSIDe CoNSultS by Cliff Rapp, LHRM
The informal consultation or “curbside” consult, is a longstanding medical practice. extending beyond the traditional “curb” – a hospital hallway or physician lounge – such consults are increasingly being conducted via cell phone and email. Quick, paperless, and cost-free information exchange benefits both physician and patient alike. While the advantages of curbside consults are many, the inherent liability should be considered and a modicum of risk management savvy initiated. a curbside consult may be defined as the solicitation of medical advice regarding a specific patient’s medical condition, care, or treatment without the consultant actually seeing the patient. Most curbside consults entail recommendations from a subspecialist. However, medical advice sought by a person other than a physician during a social function or in the hardware aisle at Home depot also constitutes a curbside consult.
determining liability exposure. 2 absent a physician-patient relationship, there is no “duty” on the part of the consultant and, thus, no basis in tort for legal action against the consultant.
Primary care physicians frequently rely on curbside consults. in a study published in the Journal of the American Medical Association, 70 percent of primary care physicians and 68 percent of subspecialists participated in at least one informal consult in a week, usually a brief hallway chat or telephone conversation.1 consults most often entailed which diagnostic testing should be obtained or treatment initiated for a patient. The subspecialties most often consulted were cardiologists, gastroenterologists, and infectious disease specialists. 2, 3
Whether the consultant had access to the medical chart; the relative experience of the physician seeking the consult;
However, the courts have applied certain criteria that define the legal parameters of a physician-patient relationship in the context of an informal or curbside consult, such as: the extent of the conversations; Whether or not the consultant had a prior physicianpatient relationship or participated in the subject’s health care; Whether the consultant did a physical examination;
Whether the consultant was paid; the relationship between the physician and consultant; Whether the patient was aware of, or requested the consult; and the extent to which the clinical situation was in any way emergent.
Ph ySICIAN - PAtIeNt rel AtIoNShIP
advice or discussions that are not patient-specific are generally not considered a curbside consult. Most courts have ruled consistently that a curbside consult does not create a physician-patient relationship – the primary factor
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Things get a little blurry when a curbside consult is sought by someone other than another physician. such solicitations for medical advice typically take place outside of a clinical setting. These are risky types of information exchanges and
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are best avoided. courts are more likely to find that a professional service was rendered, for which the physician will be held liable even if the person seeking the advice is not an established patient.
mINImIze the exPoSure
although few medical malpractice claims are attributed to curbside consults, clever legal theories abound. While it may be flattering to be consulted, consider the potential liability exposure and follow these tips:
u lt I m At e r e S P o N S I b I l I t y
What remains crystal clear in the fact that a physician who seeks informal consultation remains legally responsible for the care and treatment provided to the patient. This includes following the advice sought as well as rejecting any advice offered. consider the case of a pediatrician who discussed her patient’s case with an infectious disease specialist in the hospital’s medical staff lounge. The pediatrician recorded the advice given by the specialist and the specialist’s name in the medical chart. Because no formal consultation had been sought, the specialist was unaware of all of the medical facts. a lawsuit subsequently brought against the pediatrician also named the specialist whose medical advice, retrospectively, would have been entirely different had all the medical facts been known at the time of his discussion with the pediatrician. The inherent risk factors of curbside consults include: reliance on incomplete, inadequate or inaccurate information; the logistical disadvantages when the consult is sought external to a clinical environment; being named as a consultant in the medical record or in deposition testimony such that a physician-patient relationship is inferred; the obvious legal implications of giving off-the-cuff medical advice; and exposure to inappropriate care and treatment rendered by others for which you are held accountable.
decline curbside consults involving complex medical situations, controversial care and treatment, or when examination of the patient is warranted. Keep the informal consult simple – discussion should be brief and recommendations specific to the information exchanged. offer to see the patient in a formal consultation if the case is complex. request a formal consultation if curbside consults for the same patient are repeatedly requested. do not bill for curbside consults. do not provide curbside consults for patients in active labor, patients who are critically ill, or patients whose conditions are rapidly deteriorating. When seeking the consult, do not record the name of the consulting physician in the medical record unless the consultant is aware and in agreement. Cliff Rapp, a licensed health care risk manager, is Vice President of Risk Management with First Professionals Insurance Company, a leading medical professional liability insurer. Rapp is widely published and a national speaker on loss prevention and risk management. Information in this article does not establish a standard of care, nor is it a substitute for legal advice. The information and suggestions contained here are generalized and may not apply to all practice situations. First Professionals recommends you obtain legal advice from a qualified attorney for a more specific application to your practice. This information should be used as a reference guide only. First Professionals Insurance Company is Florida’s Physicians Insurance CompanySM and the endorsed carrier for professional liability insurance. 1. Washington School of Medicine. Risk Prevention and Control: Informal: Curbside Consultations. http://aladdin.wustl.edu/riskmgmt.nsf 2. Family Medicine 2003; 35(7):476-81. 3. JAMA, Vol. 275, No. 6, 145-147. F.A. Manian M.D. and D.A. Jansen, M.D. Curbside Consultations: A Closer Look at a Common Practice
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hIt StImuluS ProVISIoNS For PhySICIANS
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by R. David Evans
eArLy this yeAr,
Congress passed
sweeping economic legislation, the American recovery and reinvestment Act (ArrA), which appropriated $787 billion federal dollars toward economic stimulus programs throughout the country.1 Among the billions of dollars directed toward overall health care spending, ArrA allocated a significant amount of funding to develop standards and programs for the use and exchange of electronic health data. the health information technology (hit) provisions within ArrA create and fund the new office of the national Coordinator for health information technology and authorize the national Coordinator, david blumenthal, to direct investments in hit according to certain federal standards.
1. ARRA Full Text. http://frwebgate.access.gpo.gov/cgi-bin/getdoc. cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
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The office of the national coordinator was given $2 billion for the investment and implementation of HiT programs as outlined in Title Xiii of arra, also known as the HiTecH act. of this $2 billion, the secretary of Health and Human services is directed to use $300 million to support regional Health information exchange centers, leaving around $700 million to the discretion of the secretary in implementing other HiT programs and grants. in addition to the HiT funding in the HiTecH act, congress has appropriated around $20 billion for a Medicare and Medicaid physician incentive program. The physician incentive program will provide federal aid to eligible physicians who implement meaningful use of electronic health records (eHr). This article seeks to outline both the Medicare/ Medicaid incentive program and the other HiT appropriations found in the arra. meDICAre/meDICAID INCeNtIVe ProgrAm
arra allocates around $20 billion for the promotion of eHrs used for billing and exchanging health information with Medicare and Medicaid. of this $20 billion, $17.2 billion will
be allocated for individual physician incentive payments. nonhospital Medicare service providers who implement a qualified eHr system are eligible for the Medicare incentive payments.2 The incentive payments will be based on the amount of each physicianâ&#x20AC;&#x2122;s allowable Medicare service that is billed through an electronic health record system. Physicians may receive as much as 75 percent of their allowed charges as a HiT incentive, but they will be eligible to receive only up to $44,000 over a five-year period.3 Medicare providers, who are not hospital-based, are eligible to receive an incentive payment up to $18,000 during their first year of eHr implementation. The total amount of possible incentive dollars, $44,000, will be distributed over a five-year period to those physicians who adopt a qualified eHr system before dec. 31, 2012. Those physicians choosing to take full advantage of the early incentive program will be eligible to receive $18,000 in the first year of eHr implementation, $12,000 in the second year, $8,000 in the third year, $4,000 in the fourth year, and $2,000 in the fifth and final year. Physicians who do not exercise their option for early implementation, those whose first payment year is after 2012, will only be eligible for up to $15,000 for the first payment year followed by subsequent years of $12,000, $8,000, $4,000, and $2000. it is important to note, however, that physicians who use an eHr system that is capable of e-prescribing will no longer be eligible for the e-prescribing incentive program once the physician receives an eHr incentive payment, in other words there can be no double-dipping. in conjunction with the promised incentive payments for Medicare covered services, arra implements a series of penalties after year 2015 for physicians who do not implement eHr systems. Physician reimbursement for Medicare covered services shall be reduced by one percent in 2015, two percent in 2016 and by three percent in 2017 for those who have not implemented meaningful eHr use. after 2017, the HHs secretary has the discretion to increase reductions up to five percent of Medicare billing. The bill does include a significant
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Top 10 Reasons for Physicians to Asset Protect 10. $8,570,000: the verdict in Seminole County, Florida for failure to timely diagnose tuberculosis meningitis in a 5-year-old female, resulting in brain damage. Incident Date: September/1995; Trial Date: February/2007. 9. $30,000,000: the verdict in Broward County, Florida for failure to timely perform a C-section, resulting in severe mental deficiency and paraplegia of newborn. Incident date: May/1991; Trial Date: April/ 2008. 8. $35,206,000: the verdict in Broward County, Florida for failure to timely diagnose fetal distress and perform a C-section to prevent oxygen deprivation, resulting in severe mental deficiency and paraplegia. Incident Date: January/2000; Trial Date: June/2008. 7. 43%: the recovery probability for medical malpractice claims reported in Florida from 2002 through 2008. (Recovery Probability is the share of plaintiff verdicts to the total number of verdicts rendered for a specific liability.) 6. 42%: the percentage of medical malpractice combined plantiff and defense verdicts in Florida which are due to an allegation of failure to timely diagnose or an allegation of negligent surgery. 5. 16%: the percentage of the total number of combined plaintiff and defense verdicts in Florida which are in the category of medical malpractice, second only to vehicular liability. 4. $1,417,745: the median award for medical malpractice verdicts in Florida.
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hardship exception that may allow certain physicians to continue to receive full Medicare compensation without an eHr system; however, this exception will only apply to a professional for a maximum of five years.
In order to receive these incentive payments, physicians must implement and report meaningful use of electronic health records. in addition to Medicare incentives, Florida Medicaid providers may receive incentive payments if they are non-hospital-based physicians with at least a 30 percent Medicaid patient volume, non-hospital-based pediatricians with at least a 20 percent Medicaid patient volume, or physicians practicing in Federally Qualified Health centers or rural Health centers when at least 30 percent of their practice is for “needy individuals.” incentive payments for Medicaid providers can be up to $65,000 over a five-year period, but physicians cannot qualify for both the Medicare and Medicaid incentive program. While Medicare incentive payments will be made to physicians from the federal government, Medicaid incentive payments will be administered by the state. currently, Florida’s agency for Health care administration (aHca) is working with the centers for Medicare and Medicaid services (cMs) to fully define the Medicaid incentive program. in order to receive these incentive payments, physicians must implement and report meaningful use of electronic health records. originally, arra stated that a meaningful user should simply use certified eHrs (which include e-prescribing functionality), engage in information exchange, and report quality measures. This baseline definition, however, is subject to more stringent requirements based upon the determination of the Health information Technology Policy committee. The HiT Policy committee, which was created under arra, released definitions and guidelines for comment on what should constitute “meaningful use” on June 16, 2009.4 although these initial definitions from the Policy committee are for comment only, the american Medical association (aMa) has indicated some concern over the committee’s aggressive timeline to meet the proposed measures. The aMa 4. Meaningful Use Definition. http://healthit.hhs.gov/portal/server.pt/gateway/ PTARGS_0_11113_872719_0_0_18/Meaningful%20Use%20Matrix.pdf
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indicated that changes should be made in the following categories: appropriate access to, exchange and reporting of health care data; costs associated with the dissemination of information; privacy measures including ineligibility for incentives due to an alleged HiPaa violation; and patient compliance with specified measures. I m me D I Ate FuN D I N g to S tr e N gthe N h e A lt h I N Fo r m At I o N t e C h N o lo g y INFrAStruCture
arra directs the secretary of Health and Human services to invest in the overall use of electronic health information for every american by building a nationwide infrastructure for the electronic exchange of health information. Funding for overall HiT infrastructure will come from unspecified portions of the Health and Human services budget, and will be made available to the secretary for fiscal years 2009 through 2013. Funding must be used to implement the electronic architecture required for a nationwide electronic exchange of health information. The secretary also may invest in programs that promote electronic health record software for providers not eligible for support under Medicare or Medicaid. With money pouring into the system to implement this new nationwide electronic infrastructure, congress has directed the secretary to provide funding for training on the best practices to integrate HiT infrastructure. regIoNAl exteNSIoN CeNterS to ProV I De teCh N I C Al A SSI S tA N Ce to ADoPt hIt
in order to assist health care providers in adopting and implementing eHr technology, arra has directed the national coordinator for HiT to use unspecified portions of its $2 billion to support regional technical support centers. The regional support centers are directed to focus their assistance toward public, not-for-profit and critical access hospitals, and the regional support centers must be not-for-profit entities themselves. also, the regional centers shall first direct their attention to individual or small group practices that are focused on primary care. Funding is provided to the regional support centers in order to provide training and technical assistance for HiT and to disseminate best practices in accordance with the strategic plan of the office of the national coordinator. More specifically, the regional support centers will encourage adoption of electronic health records by clinicians and hospitals, assist clinicians and hospitals to become meaningful users of electronic health records, and increase the probability that adopters of electronic health record systems will become meaningful users of the technology. under current arra
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provisions, these regional centers will receive no more than 50 percent of the expenses required to maintain the center unless congress further decides that special economic conditions exist that require additional federal support. r e g I o N A l h e A lt h I N Fo r m At I o N exChANge (hIe) CeNterS
The national coordinator for HiT will establish regional Hie centers in order to facilitate and expand the electronic movement and use of health information among different organizations. state or state-designated entities shall have broad discretion to implement various Hie projects that seek to enhance broad and varied participation in health information exchange. regional Hie centers are directed to remedy barriers to health information exchange, assist patients in utilizing health information exchange, and support public health agencies in the use of electronic health information. upon receiving applications from various state organizations, the HHs secretary will have $300 million to distribute to regional Hie centers. over the past several years, aHca has collaborated with multiple stakeholders to facilitate the exchange of health information technology among different health care providers. in a draft proposal published in May 2009, aHca proposed to partner with a not-for-profit organization to establish a state-level health information 5. Florida Health Information Exchange. http://www.fhin.net/FHIN/FLHIEplan/ FloridaHIEplan05072009rev.pdf
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exchange.5 Moreover, aHca plans to submit its Hie plan to the office of the national coordinator for HiT in order to receive funding for this regional health information exchange program. The information exchange program will connect regional gateways, health care provider, health plans, consumers, data analysts, and the nationwide health information network. ComPetItIVe gr ANt S to S tAteS
The HHs secretary is directed to issue grants to individual states in order to enhance the number of health care providers utilizing certified eHr technology. Funding from the competitive state grants will be used for loan Programs to furnish individual health care providers money to establish certified eHr technology. no funds other than those allocated within these state grants can be deposited into any loan fund. The interest rates for these loans will not exceed the market interest rate, and the principal and interest payment on each loan will be required no later than one year after the date the loan is awarded. at this time, the amount of funding is unspecified as part of the $2 billion allocated to the national coordinator for HiT. R. David Evans graduated from Wake Forest University and completed his political science honors thesis on health care, focusing on the political and legal impacts of Americaâ&#x20AC;&#x2122;s pharmaceutical companies. During that time, David interned under Sen. Mel Martinez, R- Fla., as an appointed member of the Stennis Congressional Leadership Program. Currently, David is a second year law student at the University of Florida Levin College Of Law and clerks with the Florida Medical Associationâ&#x20AC;&#x2122;s Department of Medical Economics.
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Sh ShIF ShIFt IF IFt IF 52
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by R. David Evans
ShIFtINg PrIVACy CoNCerNS:
FtIN tINg t tIN INg IIN Ngg hIPAA ChANgeS uNDer the hIteCh ACt
wAshingtonâ&#x20AC;&#x2122;s reCent push
to enhance the use
of electronic health
information certainly has raised important privacy concerns. As physicians gather, store, and transfer electronic health information, new privacy regulations must cover the widespread protection of electronic personal health
information. Just as patients seek reassurance that their electronic health information will not become susceptible to a security breach, health care providers must be aware of new heightened standards. As part of the hiteCh Act,
also title Xiii of ArrA, Congress has implemented a new set of privacy standards that will significantly strengthen existing privacy regulations under the health insurance portability and Accountability Act of 1996, also known as hipAA. Among the various changes incorporated into hipAA, privacy laws now will affect both covered entities and business associates, require patient notification in the event of certain breaches, and increase civil monetary penalties for hipAA violations.
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New buSINeSS A SSo CIAte requIremeNt S
Before the new HiTecH act provisions, old HiPaa laws applied only to health plans, health care clearinghouses, and most health care providers that were referred to as “covered entities.” other third party businesses requiring protected health information, referred to as “business associates,” had only a contractual obligation with a covered entity to prevent the disclosure of a patient’s protected health information; there was no direct legal obligation under HiPaa. Following the new HiTecH act, however, all business associates now will be directly liable under HiPaa for privacy and security breaches.1 examples of these thirdparty business associates include a third-party administrator that assists a health plan in claims processing, a cPa firm that accesses patient information, an attorney whose legal services include access to protected health information, a consultant who performs utilization reviews for a hospital, or an independent medical transcriptionist. now, criminal and civil penalties will apply directly to business associates if they fail to maintain HiPaa’s security and privacy rules dealing with administrative safeguards, physical safeguards, technical safeguards, and other privacy provisions.2 any new security and privacy requirement under the HiTecH act must be incorporated into new or existing business associate contracts between the business associate and the covered entity. Business associate contracts are required for certain business associates that provide data transmission of protected health information. new Health information exchange organizations, regional Health information organizations, e-prescribing gateways, and software vendors offering personal electronic health records require business associate contracts with each covered entity. ultimately, any business associate that requires access to protected health information will now be treated identical to the covered entity, and will be directly liable for failing to meet HiPaa standards. b r e ACh N otIFI C AtI o N r equ I r eme Nt A N D ACCouNtINg For DISCloSureS
one of the most important impacts of the new HiTecH act security provisions is that patients must be notified if their unsecured health information is disclosed to any unauthorized person or entity. While old HiPaa laws did not obligate a covered entity to report the breach of an individual’s health information, notification now is required after any unauthorized disclosure of protected health information.3 a “breach” is defined as the unauthorized acquisition, access, use, or disclosure of unprotected health information that compromises the security of the information. Health information is considered secure, not susceptible to breach, only when it complies with technology
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requirements outlined by the secretary of the department of Health and Human services. in other words, if the unauthorized health information that is disclosed is unusable, unreadable, or indecipherable, then the information is sufficiently protected and will not constitute a breach of “unsecure” protected health information. it is important for health care providers to ensure that any electronic health record system complies with these requirements in order to protect health information in the case of a breach.
minimum amount of health information that is required. under previous HiPaa laws, patients could request that disclosure of their health records only be made for treatment, payment, and health care operations, but providers were not required to grant these requests. under new HiPaa changes, covered entities are required to grant these requests and withhold certain patient information from health plans if the patient is paying out of pocket for health care services. I N C r e A S e D Pe N A lt I e S A N D e N Fo r C e m e N t
under new laws, however, the disclosure of protected health information will not constitute a breach if the disclosure is a result of the unintentional access of information by an employee only if that disclosure was made in good faith, was within the scope of employment, and was not further disclosed by any other person. in the event of a breach, the covered entity must notify each individual whose unsecured health information was reasonably believed to be disclosed, and they must do so within 60 days. a notification should include a brief description of what transpired, a description of what information was disclosed, steps the individual should take to protect themselves from further harm, and a brief plan of what the covered entity is doing to remedy the breach. any business associate that is aware of a breach must notify the covered entity of the breach and identify each individual whose unsecured health information has been acquired. The covered entity must provide notice to individuals either by first class mail or email if the patient has authorized email contact. notably, if a breach involves the disclosure of more than 500 records, the covered entity must place notification of the breach in a prominent media outlet and must immediately notify the secretary of Health and Human services (HHs) of the breach. all covered entities must maintain a log and report the number of breaches annually to HHs.
The HiTecH act increases civil monetary penalties for different HiPaa violations ranging from $100 to $1.5 million.4 The new penalty provisions implement a three-tiered penalty system wherein different levels of sanctions are applied according to differing levels of culpability, namely: (1) whether the covered entity knew of the breach of privacy, or should have reasonably known; (2) whether the breach was due to reasonable care and not willful neglect; or (3) whether the breach was due to willful neglect. Willful neglect is defined as knowing of a privacy and/or security issue, but refusing to take action to correct such a deficiency. if a breach occurred while the covered entity was exercising reasonable diligence, or would not have reasonably known of the breach, a $100 sanction may be imposed with no more than $25,000 in any given year for similar violations. if the breach was due to reasonable cause, but not willful neglect, a $1,000 sanction may be imposed with no more than $100,000 imposed in any given year. lastly, if a breach was due to willful neglect, a $50,000 sanction may be imposed with no more than $1.5 million in any given year.
covered entities also are required to provide patients, upon request, with an accounting of previously disclosed health information. although old HiPaa regulations required a similar disclosure upon request, the new HiPaa rule removes certain exceptions that allowed covered entities to withhold information involving certain disclosures. Previously, entities did not have to report disclosures made for the purposes of treatment, payment, or health operations as most patients expected these types of health record disclosures. now, disclosures of electronic health information made in the course of treatment and hospital operations, a previous exception, must be included in any accounting provided to a requesting party.
under the new HiTecH provisions, employees of covered entities are liable for HiPaa violations and are subject to civil or criminal penalties. although the department of Justice limited criminal enforcement to HiPaa-covered entities in the past, the HiTecH act has amended this to clearly state that an employee or other individual can be found criminally liable for wrongfully obtaining or disclosing protected health information without authorization. also, state attorneys general now are granted authority to seek damages and/or fines for privacy and security violations in their respective states.5 on behalf of the interests of their citizens, state attorneys general may receive up to $25,000 per year for each type of violation by a covered entity. even more, within three years after the enactment of the HiTecH act, the secretary of HHs must publish regulations outlining how certain individuals can receive a portion of the monetary penalties imposed as a result of HiPaa violations.
Pursuant to the HiTecH act provisions, any entity that is releasing protected health information must release only the
1 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13401 2 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13404 3 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13402
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These increased enforcement mechanisms certainly will lead to more oversight and investigation for covered entities as they move forward with implementing electronic health record systems. although HiPaa penalties were formally complaint driven, new HiTecH act provisions require HHs to audit both covered entities and business associates on a periodic basis starting one year after the enactment of these provisions.6 The secretary of HHs will also conduct a study on privacy and security requirements for entities that are not considered covered entities or business associates. Taken in total, increased penalties and enforcement make it imperative for health care providers to assess their current security and privacy practices.
transfer of electronic health information between different facilities and healthcare providers. signed into law on June 16, 2009, the act seeks to ease certain privacy requirements in order to enhance electronic health information exchange.7 Beyond defining new terms related to electronic health records, the act instructs the agency for Health care administration (aHca) to develop a universal patient authorization form. The authorization form will authorize the release of electronic health information for certain circumstances, and it will provide immunity for health care providers who release identifiable health records in reliance on the authorization form.8 aHca is instructed to develop both a paper and electronic version of the form by July 1, 2010.
r e Co m m e N DAt I o N S Fo r h e A lt h CAre ProVIDerS
enforcement dates of many HiTecH act provisions vary, but most of the HiPaa changes will go into effect sometime in the year 2010. importantly, the new penalty provisions and attorneys’ general cause of action provisions already are in effect. despite the fact that some new HiPaa requirements are not yet effective, physicians should take some important steps to prepare their practices for implementing the new privacy requirements. Health care providers should educate their staff on all upcoming changes while emphasizing that HiPaa regulations will be subject to heightened penalties and stricter investigation. With HiPaa regulations applying directly to business associates, health care providers should assess carefully which business associates they choose to utilize. Physicians should review breaches and other disclosures by their current business associates and review the associate’s internal security policies. now that the stakes are higher, many health care providers may reassess which business associates they choose to work alongside. Providers should make sure they are remodeling the language in their business associate agreements to comply with the current regulations. despite the important security changes already taking shape, other security regulations are sure to take hold as electronic record programs are more commonly utilized and new security hazards are identified. The HiTecH act allocates more than $1 billion for comparative effectiveness research, which may translate into additional security needs. Hence, health care providers must stay up to date on new HHs regulations and changing privacy laws as the transfer and storage of health records changes throughout the state. Ne w Flo r I DA Pr IVAC y l Aw
gov. crist recently approved senate Bill 162, The Florida electronic Health records exchange act, pertaining to the
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The Florida electronic Health records exchange act also authorizes the release or access of identifiable health information without patient consent for use in the treatment of an emergency medical condition.9 if the patient is facing an emergency condition and consent from the patient or patient representative is unattainable, health care providers may in good faith release or access a patient record in any medium and the healthcare provider will remain immune from civil liability. Florida statutes define an emergency medical condition as one manifesting acute symptoms of sufficient severity, including severe pain, which could result in severe jeopardy to a patient’s health, serious impairment to bodily functions, or serious dysfunction of any bodily organ.10 any person who forges a signature, materially alters an authorization form, or obtains authorization under false pretenses may be liable to the patient or health care provider for compensatory damages. lastly, the act amends current Florida law to allow for the release of clinical laboratory results to a physician other than the ordering practitioner if the test results are needed for the care or treatment of that patient.11 These new privacy provisions will allow for the increased exchange of electronic health information between different hospitals and providers throughout the course of treatment. The Florida legislature intends to ease the ability for physicians to use health information technology in order to promote cost-effective access to the medical information needed to make sound decisions.
4 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13410 5 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13410 6 See American Recovery and Reinvestment Act, Pub. L. 111-5, §13411 7 MEMORANDUM: Governor CRIST’S BILL ACTIONS TODAY, JUNE 16, 2009. http://www.flgov.com/release/10841 8 Chapter 2009-172, Laws of Fla.; s. 408.051(4) 9 Chapter 2009-172, Laws of Fla.; s. 408.051(3) 10 Section 395.002(8), F.S. 11 Chapter 2009-172, Laws of Fla.; s. 483.181(2)
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DeClArIN INDePeND
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INg NDeNCe
by FMA Center for Health Care Policy
meDICAl StAFF DeVeloPmeNt
At hoSPItAlS gIVeS PhySICIANS leVerAge.
reLAtions between physicians and hospitals have been strained for years, and with health care reform on the way, are likely to become worse. hospitals are hiring greater numbers of physicians and are buying medical practices in order to maintain consistent staffing and to impose greater control in all aspects of treatment. Further, hospital administrations have become more able to adopt bylaws that reduce the ability of physicians to maintain independent practices. this problem is especially apparent for medical specialties that rely on access to hospital resources. As Congress considers health care reform, it is important for physicians to position themselves in a manner which will give them leverage in dealing with hospitals in their communities. developing an independent medical staff at your hospital is critical in this process.
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all Medicare reform proposals are designed to contain costs and decrease utilization within the program. Put simply, the current fee-for-service system will be extinct sometime in the near future. The ramifications of this extend well beyond the Medicare program itself, and will affect the way that hospitals and physicians approach patient care, reimbursement, and contracting across the board. This white paper describes various Medicare payment reforms that are being considered, with special attention to the concept of “bundling,” and then describes some pros and cons of these proposals. each of the proposed Medicare payment reforms highlights the strong need for maintaining independent medical staff at hospitals. Without independent staff, hospitals soon will have an even greater ability to leverage control over physician reimbursement as well as all aspects of patient care, such as admission procedures, authorization for treatments, and so on. There are ways that physicians can pool resources to create parity between hospitals and physicians. A lt e r N At I V e PAy m e N t m e t h o D o l o g I e S1
The consensus is that fee-for-service payments encourage over-utilization of services and lack incentives to improve the efficiency or quality of care. Proposals have emerged with the intent to control volume growth, to align incentives to reward appropriate and high-quality care, and to discourage the use of unnecessary resources. alternative payment methodologies that are currently being proposed include: (1) Bundled Payments Models, (2) gainsharing Models, and (3) Medical Home Models. These models are not mutually exclusive. one or more, or a combination of these methodologies, may be incorporated into Medicare proposals or policies. For all three alternative payment models, there are many pros and cons. b u N D l e D PAy m e N t S m o D e l S
in this methodology, a single payment is made for an array of health care services during inpatient visits as well as services provided within a specified amount of time following a patient’s discharge. in one scenario, a lump sum payment would be made to the hospital by Medicare for all services provided, including physicians and all post-hospital care (rehabilitation, home health care, durable medical equipment, and readmissions). This suggests that hospitals will be controlling a significant portion of the Medicare budget and, as a result, physicians may lose autonomy. There are different models for bundled payments, which range from grouping claims into “episodes of care,” where physicians’ payments would be based on all care delivered during a period of time, to virtual bundling, where payments would remain fee-forservice; however, data would be collected to create
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benchmarks, and physicians would become eligible for additional payments if they meet certain standards. a third bundling model would involve assigning physicians to “accountable care organizations” (acos) that would be responsible for overseeing the quality of care and Medicare spending for their patients. acos would be subject to
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bonuses or penalties for meeting benchmarks and would pay physicians on a fee-for-service basis with some amount withheld and paid after the acos annual performance review. gAINShArINg moDelS
in this methodology, hospitals share with physicians some savings produced as result of changes in care processes. also referred to as “shared savings” or “shared accountability,” this approach could align incentives for hospitals and physicians to provide cost-effective care, such as by encouraging more appropriate use of diagnostic testing, greater prescriptions for generic drugs, reductions in medical errors, use of outpatient services and disease management services that reduce hospital admissions, and reducing preventable readmissions. gainsharing can be a component of bundled payment methodologies. meDICAl home moDelS
in concept, the “medical home” takes responsibility for managing and coordinating patient care and provides greater access to care through expanded hours and new communications options, including the use of health information technology and potentially some pay-forperformance measures. To be considered a medical home, there is a recognition process developed by the national committee on Quality assurance. The medical home concept offers to improve patient care at little extra cost, while increasing payments to primary care practices. This model still is evolving and many questions remain about how it should be structured. I m PlI C AtI o N S o F b uN DleD PAy m e N t S F o r t h e P r AC t I C e o F
program, the dynamics created by these policy shifts will affect all aspects of the practice of medicine. There is growing concern that through the incentives created by bundling payment, hospitals will become more motivated to sprawl and will begin to acquire rehabilitation facilities and home health care entities, potentially stifling out organizations that are not affiliated with them. Further, hospitals will be more motivated to hire their own physicians, such as radiologists, cardiologists, surgeons, and other specialties that practice primarily in hospitals, along with becoming more motivated to purchase primary care practices in order to increase their catchment of patients. ultimately, the private practice of medicine will be threatened as hospitals begin to control most aspects of health care. This real possibility brings various scenarios to mind: » a cardiologist’s patient is admitted by a hospitalist for congestive heart failure, but the patient’s cardiologist is not consulted in order to keep costs down. » a gastroenterologist admits his or her own patient and ends up treating the patient’s diabetes and coPd without assistance in order to keep costs down. » an obstetrician is told his or her privileges have been suspended because he or she performs too many cesarean sections and his or her costs are too high. » a pediatrician is told that an in-hospital pediatrician will admit his or her longstanding patient.
meDICINe
Bundled payments raise a number of issues and concerns, as discussed above. These issues are most pressing for physicians who rely on hospital access for patient treatments, as well as physicians across specialties. although Medicare payments may appear to only affect those enrolled in the
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the Im P o r tA N Ce o F INDePeNDeNt meDIC Al S tAFFS
regardless of which Medicare payment model is adopted, it is imperative that doctors establish independent medical staffs to fight for their rights. Presently, most medical staffs in
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» CrEdEntiAling: Bundling payments is likely to lead to financial credentialing, which could result in reducing competition among providers, dissuading doctors from seeing patients in the hospital, and diminishing the quality of care as physicians become risk averse or discontinue performing cutting edge (and probably more expensive) procedures. independent medical staffs can prevent the development of financial credentialing. » outPAtiEnt sErviCEs: non-hospital associated rehabilitation facilities may be stifled out as hospitals leverage their bundled payments to steer patients to entities they control. an independent medical staff can ensure that all rehabilitation facilities and home health care agencies are used fairly and equally. » inPAtiEnt sErviCEs: currently, there is nothing to stop hospitals from requiring all admissions to go through hospitalists. some hospitals already require this to be the case in icu admissions. This eventually could make doctors lose control of their patients when they are admitted. an independent medical staff can prevent this from occurring by mandating that the patient’s physician has the option to be the primary admitting physician.
Florida are not independent: They do not have independent legal counsel (the hospitals provide this when bylaws changes are made), the chief medical officer of the hospital is typically an employee of the hospital, and Medical executive committees (Mecs) meet in the presence of hospital administrators and staff. not too infrequently, the members of (Mecs) are co-opted by their hospital administrations and do not necessarily represent the true interests of the medical staff. The following are some of the areas in which having an independent medical staff will be beneficial for physicians: » Er CAll: With an independent medical staff, physicians could ensure that emergency room (er) call is not mandatory for maintenance of staff privileges. This would force hospitals to pay physicians for taking er call, thus distributing bundled payments more equitably and ensuring that doctors do not continue to provide free services to hospitals.
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» strAtEgiC PlAnning: as noted above, Mecs at hospitals meet in the presence of hospital administrators, the chief medical officer who is employed by the hospital, and the legal counsel used to rewrite the bylaws and is hired by the hospital. The Mec may not be able to fairly represent physicians in this type of environment. The issues raised by alternative payment methodologies require coordination of resources and planning across medical groups within each community in Florida. it is in the hospitals’ interest to keep the status quo, because physicians will be less able to develop an independent plan of how to address bundling. an independent medical staff can and should meet without hospital administrators to promote the medical staffs’ interests. StePS to AChIeVe INDePeNDeNt meDIC Al S tAFFS
To develop an independent medical staff, hospital dues may have to be raised substantially in many hospitals to pay for independent counsel and possibly the chief medical officer position. some hospitals do not make payment of dues mandatory, and for those that do, the amount is insufficient to fund an independent medical staff. some medical staffs keep the payments low in order to attract physicians who generally do not admit to the hospital, and some physician membership may be lost. it is imperative that physicians should take control of the medical staff process. The bottom
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line: Physicians have to quickly rethink short- and long-term strategies as they relate to hospitals in order to address the many dramatic and consequential changes in progress. The FMa is developing several resources to help you in the process of implementing an independent medical
staff at your hospital. a Task Force on Medical staff autonomy will be appointed and will work to provide sample medical staff bylaws, a list of hospitals that have independent medical staffs, and other resources. This information will be made available to you on the FMa website in the near future.
Summary of major options for Changing medicare Physician Payment Policy Written for the American Medical Association by Health Policy Alternatives, Inc. b u N D l e D PAy m e N t S o P t I o N
mAjor ProS
mAjor CoNS
• Concept already used by Medicare to pay hospital inpatient services and global surgical services (among others).
• Concept not yet well developed when bundle includes services provided by multiple independent providers.
• Could provide incentives for reducing the costs of patient care. • If bundle includes both hospital and physician services, could permit physicians to share in any savings produced by changes in patient management.
• Key unanswered questions relate to the contents of the bundle, the appropriate recipient(s) of the bundled payment, how to allocate the bundled payment amounts, and how to risk-adjust these payment amounts. • Physicians could have difficulty accessing payments if funds are controlled by hospitals. • Option could have limited relevance for physicians whose practices involve little hospital-related care. • Could create competitive environment between groups of physicians.
gAINShArINg oPtIoN
mAjor ProS
mAjor CoNS
• Would allow physicians to share in savings produced by reducing hospital costs.
• Physicians could have difficulty accessing payments if funds are controlled by hospitals.
• Would be compatible with existing Medicare payment policies (each provider would be paid as they are today, but hospitals also could share savings with the physicians who helped produce them).
• Ongoing, sharable savings could be difficult to sustain.
• Could provide incentives for reducing the costs of patient care and improving patient outcomes. • Ongoing public disclosure of hospital performance data would make it possible to monitor, at least to some extent, the impact of gain sharing.
• Option would have limited relevance for physicians whose practices involve little hospital-related care. • Policy makers could end up imposing too many conditions on the use of gainsharing. • Could increase professional liability exposure.
meDICAl home oPtIoN
mAjor ProS
mAjor CoNS
• Could increase payments to physician practices serving as medical homes, many or most of which are likely to be primary care practices.
• The medical home concept continues to evolve, and there is not widespread agreement on the essential features of a medical home.
• Would provide incentives to better coordinate patient care, thereby improving patient outcomes and potentially reducing health care costs (e.g., by reducing emergency department visits and avoidable hospitalizations).
• It may be a challenge for some practices to meet the care management and information technology requirements to qualify as a medical home.
• Could make primary care more attractive to medical students and residents. • Could provide an incentive for physicians to invest in health information technology. • Could stimulate development of interoperable HIT network.
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• Might increase Medicare expenditures, especially if the primary outcome is increased utilization of underused services. • If subject to budget neutrality requirements, increased payments to medical homes would require reductions in spending for other Medicare services.
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THE HEA LTH LAW FIRM MA IN OFFICE t 1101 DOUGLA S A VENUE t A LTA MONTE S PRINGS , FL 32714 T ELEPHONE: (407) 331-6620 t (850) 439-1001 t T ELEFA X : (407) 331-3030 BRA NCH OFFICE t 37 N. ORA NGE A VE., S TE. 500 t ORLA NDO, FL 32801 BRA NCH OFFICE t 201 E. GOVERNMENT S TREET t P ENSA COLA , FL 32501 W EBSITES t WWW .T HEHEA LTHLAW FIRM.COM t WWW .HEA LTHA TTORNEYS .COM
REPRESENTATION OF HEALTH PROFESSIONALS George Indest is board certified by the Florida Bar in the specialty of Health Law and is available to accept referrals of health care clients or to act as cocounsel on health care cases state-wide. We represent health care professionals.
G EORGE F. INDEST III, J.D., M.P.A ., LL.M.
• Medicare/Medicaid Audit Defense • Foreclosure Defense
t Over 20 Years legal experience t Former General Counsel of Teaching Hospital t LL.M. from George Washington University t Admitted in Florida, Lousiana and D.C. t Board Certified by the Florida Bar in Health Law
• DOH/AHCA Investigations • Administrative Hearings • Medicare/Medicaid Fraud Defense • Professional Licensing • Medical Board Cases • Collections
• Medical Malpractice Defense • Debtor Defense • Insurance Company Audit Defense • Regulatory Hearings • Preparation/Litigation of Physician Contracts • Managed Care Contracts • Nursing Board Cases
• National Practitioner Data Bank
• Corporations, LLCÕ s, Partnership and other Business Entities
• Hospital Credentials Hearings
• Sales/Purchases of Medical Practices
• Physician Contracts • Partnership Dissolutions • Covenants not to Compete
• Peer Review Defense
• Commercial Litigation
• PhysicanÕ s Personal Counsel
• Physician Contracts • Medicaid Appeal Hearings • Disciplinary Proceedings • Substance Abuse (PRN/IPN) • Apellate Practice • Bankruptcy
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MICHA EL L. S MITH, J.D., R . T . t t t t t
B.S., Nova Southeastern University J.D., Stetson Univ. College of Law Registered Respiratory Therapist Licensed in Florida Board Certified by the Florida Bar in Health Law
JOA NNE KENNA , J.D., R .N . (ILL)
• Risk Management Investigations • Due Diligence Investigations
t J.D., Stetson Univ. College of Law • Opinion Letters t B.A ., Business Management, National Louis University (with honors) • Complex Litigation t Diploma, St A nne’s Hospital School of Nursing • Medical Staff Bylaws t Licensed in Florida
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bAby
the AgINg oF theboomerS by John Agens, MD
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AND the Future oF PhySICIAN PrACtICeS
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the grAying of our population will have profound effects on ALL MediCAL speCiALties in the united states. As situational awareness is taught by the military to increase success in survival situations, awareness of the operational and fiscal impacts of our changing demographic, including the impact of new technology, is essential for all physicians. understanding the needs and expectations of the aging health care consumer and their caregivers will help practices survive and even thrive.
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the key ImPACtS thAt muSt be reCogNIzeD INCluDe : FISCAl
Those born between 1945 and 1964 – the baby boomers – are reaching retirement age now. This group – all active voters – communicated their priorities in the 2008 united states presidential and congressional elections. The Health and Human services discretionary budget authority has been projected to increase from a baseline $70.5 billion in 2008 to $78.5 billion in 2009 and $76.8 billion in 2010. This does not include $22.4 billion from the recovery and reinvestment act of 2009. also not included is a proposed 10-year, $630 billion down payment on a reserve fund for health care reform, a move toward health insurance coverage for all americans. While these dollars are not targeted exclusively to baby boomers, how they are prioritized will affect the baby boomers and those who care for them in light of anticipated changes in Medicaid and Medicare. The impetus for change is being driven by cost increases in baseline Medicare and Medicaid entitlement spending that outpaces inflation. unchanged, the current system will not survive. CAregIVerS
The “sandwich” generation, those caring for both aging parents and growing children, will demand creative solutions for both populations. crises also will be opportunities for those practices that prepare. PrACtICe DeSIgN
Practices that proactively redesign their care for the aging population likely will fare better than those that react to the changing environment. The quest for higher quality at lower cost will drive a Medicare and Medicaid research agenda that will use databases to look at the value of services delivered. new funds for demonstration projects that aim to provide higher quality at lower costs will be available. education of beneficiaries about the services they are receiving will also be a funding priority. AgINg CoNSumerS
aging beneficiaries, armed with more information, will demand medical practices that suit their needs. The baby boomers are certainly a generation of consumers. compared to their younger cohorts, they tend to base their decisions more on emotion and quality of life issues. teChNology
nineteen billion dollars is included in the recovery and reinvestment act of 2009 for the accelerated adoption of health care technology. Temporary incentive payments from Medicare for adoption of certified electronic health records will
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begin in 2011, followed by a financial penalty for not using them beginning in 2015. electronic health records changes, some mandated and some driven by aging consumers, may help practices become more efficient. one area in which new technologies already are featured is in the area of cancer diagnosis and treatment. geNerAl CoNCePtS
increasing involvement of families in caregiving decisions is anticipated and could be leveraged to improve value. caregivers can provide communication links during transition from home to hospital to rehabilitation centers and, again, returning home, while improving outcomes and lowering costs. The increased need for transportation services between facilities will require creative solutions. consumers will expect a practice design that is accessible to the elderly and their families. Hearing and visual impairment of patients and their caregivers will make it necessary for information to be written in large print formats. consumers increasingly will monitor costs and, armed with medical evidence, demand medication reconciliation between caregivers. office services such as userfriendly office facilities, improved communication skills by office personnel, easy to understand outcomes measures, and advanced care planning will facilitate health care delivery. electronic health records increasingly will be mandated. Those who utilize computerized medical records for information transfer will reap the biggest clinical benefit for their patients. linking clinical practice and practice management systems will improve patient follow up and information transfer. How physicians will be compensated for this investment remains unclear. all of these issues will have profound impacts on the delivery of services to this population. in addition, all sPecialTies Will Be aFFecTed. orthoPeDICS
increased demand for orthopedic procedures and orthopedic surgeons is a certainty. Hip fractures and other trauma in the fastest-growing demographic – those over the age of 80 – will continue placing strains on Medicare reimbursement. obtaining the highest quality for the best value will be a public priority. it will be expected that practices will work with their hospitals and rehabilitation facilities to measure outcomes and demonstrated value. centers of excellence should emerge. orthopedic practices will ensure efficient management of preoperative assessment of increasingly frail and complex joint replacement patients. similar challenges have been addressed successfully in the peri-operative management of patients in inpatient geriatric orthopedic units in australia. research has
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demonstrated that the risk of falling is reduced with vitamin d supplementation and increased with polypharmacy. orthopedic surgeons will collaborate with geriatrically savvy community providers so that the demand for fracture management in the elderly does not consume their practices to the exclusion of sports injuries and elective cases. improved technologies also may result in more cost-effective hardware and surgical techniques that will last a lifetime.
evaluating the geriatric caregiver to this population will challenge pediatricians. They will need to be familiar with the basic fundamentals of assessing the elderly for their capacity to provide care. They will also need to be skilled to recognize the warning signs of dementia. offices of pediatricians should be elder friendly as well as child friendly. specifically, instructions must be easy to hear and read. m e D I C A l S Pe C I A lt I e S
g e N e r A l , VA SCu l A r , u r o lo g I C A l , gyNeCologICAl, etC., Surgery
demand for surgeons, especially general surgeons, will increase and shortages may become critical. This population’s frailty mandates appropriate peri-operative management to avoid undesired outcomes. The risks are even higher for emergency surgical procedures that are associated with a very high mortality rate over the age of 80. new developments are yielding less invasive procedures with improved effectiveness and reduced complications. education of caregivers in the pre- and postoperative environment will make them better partners and achieve improved outcomes. When catastrophic outcomes occur, as they inevitably will, caregiver education and support will help the transition to palliative care that families can accept. Hospice care is a valuable resource that also will assist this transition.
as a result of resource constraints on Medicare and flat or declining reimbursement, access to care is threatened. The number of chronic diseases per patient will increase, placing severe financial strains on the system. The recovery and reinvestment act of 2009 includes an unprecedented $1.1 billion for “effectiveness research.” The stated goal is to determine which medical treatments work best for certain conditions. consumers, however, will continue to demand patient-centered care. They will expect that their physicians will consider their quality of life and their need to be available to their family. Pain control will be a priority. Many specialties (e.g., rheumatology), already in short supply, may need to serve more as a resource to their colleagues in addition to providing direct care. The demand for cosmetic services by all patients will exacerbate the shortage of certain specialties (e.g. dermatology) to the elderly, hindering access to care.
PeDIAtrIC S
For a number of reasons, many children, especially those in medically under-served communities, depend on grandparents and other elderly relatives and friends as their primary caregivers. Medicaid is frequently their safety net. on the average, the federal government pays 57 percent of each state’s Medicaid costs. The recovery act of 2009 temporarily increased Medicaid rates during this economic downturn to help states maintain their current programs. The children’s Health insurance Program reauthorization act of 2009 extends that program through 2013 by providing $44 billion above baseline funding. Four million children will be added to the insurance rolls and, it is hoped, they will have better access to care. This is less likely to occur in states that do not adequately compensate providers. additional funding for early Head start, Head start, and child care and development Block grants should increase the number of children served. However, there remains the threat that elder care will divert resources away from pediatric care. Medicaid provides a large part of the states’ long-term health care budgets (nursing homes) and it is a significant part of an increasing drain on state resources.
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A D u lt Pr I m A ry C A r e
a study in the Feb. 17, 2009, issue of the annals of internal Medicine suggested that the typical primary care clinician must coordinate care with 229 other physicians working in 117 different practices in caring for their Medicare patients. The vast majority of this is due to the roughly 31 percent of the patients who have four or more chronic conditions. all of this will intensify over the next 20 years. Primary care physicians, no matter how dedicated, will not be able to accomplish this coordination alone. The 75 percent of primary care practices that have five or fewer physicians will not have the resources to handle these challenges. instituting electronic communications systems will be even more difficult. With a large number of providers nearing retirement, these financial challenges will need to be addressed for primary care to have a viable future. Three hundred and thirty million dollars in the recently passed federal budget was allocated to loan repayment programs for physicians, nurses, and dentists who agree to practice in underserved areas. seventy-three million dollars will be targeted to improve health care infrastructure and community partnerships in rural areas. Volunteer or reduced workload options for retired doctors will abound against a background of primary care shortage. Providers will need to be familiar with online clearinghouses for community resources and possess a working knowledge of local senior centers. Practice redesign resembling a patient-centered medical home will likely be necessary to accomplish the care coordination needs of patients and to hopefully qualify for third party reimbursement to help pay for this change. non-physician staff will likely take over many of the care coordinating functions and tracking functions in the practice. There will be more evidenced-based guidelines specifically targeted to the frail elderly and geriatric syndromes â&#x20AC;&#x201C; incontinence, falls, delirium, dementia, polypharmacy, and weight loss. These may take priority over disease-based guidelines. Targeted care of complex cases will be essential to help wisely spend the 75 percent of Medicare dollars that go to the minority of patients
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with five or more chronic conditions (congressional Budget office figures). consumers will demand patient-centered care that takes into account their values, prognosis, and quality of life. individual consumers and the public at large will expect that the system they seek care in is organized to â&#x20AC;&#x153;first do no harm.â&#x20AC;? This means practice access to decision support tools to be used by the primary care physician to avoid medications that are either not indicated, harmful, or both. errors will be more likely to cause harm in the frail elderly than in younger patients. attention will be drawn to the high cost of low quality. consumers also will demand the information contained in decision support tools to prevent medical errors. The cost of defensive medicine must be recognized and the development of alternative dispute resolution systems must be enabled. electronic information systems and electronic prescribing with links to other parts of the health care system (hospitals,
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pharmacies, and other providers) is on the horizon, but for the 80 percent of the primary care doctors who do not yet have these systems, financial assistance to acquire these resources almost certainly will be needed. simply mandating this will not, because of significant barriers, produce results. such issues are not limited to primary care practices.
opportunities will grow. successful geriatricians will need to be able to help these public and private sector entities develop systems that will meet the needs of the chronically ill, the dying, the cognitively impaired, and the physically impaired. only a lucky few geriatricians will have the time and resources to care for the healthy old.
ger I Atr I C S
Medical practice for the oldest and sickest should be designed around access to primary care that is linked to coordination of care services within the practice and the community. The number of community links will escalate beyond home care, adult day care, and assisted living as consumers demand new services that keep them and their families out of nursing homes. Physicians who are concerned about accountability of coordination of care services will need to make their voices heard and participate in the solutions. Multiple stakeholders will attempt to meet the needs of the elderly. successful geriatricians will need to be comfortable as leaders and working members of teams consisting of professionals, consumers, leaders of non-profits, and leaders of other institutions. geriatricians are also going to need to find creative news ways to act as meaningful support for struggling primary care physicians and specialists. They also will need to
The growth of the oldest old in the population is far outpacing the growth in the supply of geriatricians that already are in short supply. in a free market, the supply and income of geriatricians would reach equilibrium; however, under the current system of government imposed price controls, this scenario is unlikely. in addition, geriatricians will tend to be employed for their ability to develop new programs for the elderly and in teaching the physician workforce how to handle the demands of an aging baby boomer population. increasingly, specialists in geriatric care will be involved in efforts of non-profit organizations whose mission it will be to help the caregivers of the elderly navigate a health care system that is really not designed to care for the chronically ill. opportunities will arise in the private sector because of demand. Hospice and palliative care
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extraordinary growth of the private sector and, especially, government. increasingly, they will demand high levels of service in every aspect of their lives especially in matters affecting their health. compared to the preceding “greatest generation,” which survived the great depression and World War, the boomers have extremely high and at times unrealistic expectations, from our profession. When asked if they want high quality or low cost, they respond, “Both!” since these prospects will be difficult to reconcile, it is prudent that we, along with our professional organizations, prepare as best we can for the inevitable collision. SeleCteD bIblIogrAPhy 1. Bishai d, Trevitt Jl, zhang Y, et al. risk factors for unintentional injuries in children: are grandparents protective? Pediatrics. nov. 2008;122(5):e980-987. 2. Broe Ke, chen Tc, Weinberg J, Bischoff-Ferrari Ha, Holick MF, Kiel dP. a higher dose of vitamin d reduces the risk of falls in nursing home residents: a randomized, multiple-dose study. Journal of the americam geriatrics soc. 2007 Feb;55(2):234-9. 3. chong c, christou J, Fitzpatrick K, Wee r, lim WK. description of an orthopedic-geriatric model of care in australia with 3 years data. geriatr gerontol int. Jun 2008;8(2):86-92. 4. coleman, e. a., c. Parry, et al. (2006). The care transitions intervention: results of a randomized controlled trial. arch intern Med 166(17): 1822-8. 5. Fung HH, carstensen ll. sending memorable messages to the old: age differences in preferences and memory for advertisements. J. Pers. soc. Psychol. Jul 2003;85(1):163-178. 6. institute of Medicine committee on the Future Health care Workforce for older americans. retooling for an aging america: building the health care workforce. 2008; http://www.nap.edu/catalog/12089.html. accessed March 4, 2009. 7. Kirstin g. nichols, david r. Prytherch, Micheal F. Fancourt, William T. c. gilkison, stephen M. Kyle, damien a. Mosquera. risk-adjusted general surgical audit in octogenarians. anz Journal of surgery 2008;78 (11): 990-994 8. Pham, H. H., a. s. o’Malley, et al. (2009). Primary care physicians’ links to other physicians through Medicare patients: the scope of care coordination. ann intern Med 150(4): 236-42.
serve as a resource to residency programs and medical schools to prepare them for the future. The challenges are daunting, but there has never been a better time to be a geriatrician! The 80 million baby boomers are idealists to be sure. This “Me generation” in practice has lived through an era of
9. sloane Pd, cohen lW, Konrad Tr, Williams cs, schumacher Jg, zimmerman s. Brief communication: physician interest in volunteer service during retirement. ann. intern. Med. sep 2 2008;149(5):317-322. 10. smith sP, Barefield ac. Patients meet technology: the newest in patientcentered care initiatives. Health care Manag (Frederick). oct-dec 2007;26(4):354-362. 11. Warshaw ga, Bragg eJ, Fried lP, Hall WJ. Which patients benefit the most from a geriatrician’s care? consensus among directors of geriatrics academic programs. J. am. geriatr. soc. oct 2008;56(10):1796-1801.
About the Author : John agens, Md, is an associate Professor of geriatrics at Florida state university and is board certified in geriatrics and internal Medicine. dr. agens earned his medical degree from rutgers university in 1986. He has practiced geriatrics in solo practice, a multispecialty group practice, and in a non-profit community HMo prior to joining Fsu full time in 2008. His research interests include improving functional status in high-risk patients, medical errors post-hospital discharge, using patient self-reported health to predict mortality, patient-centered medical home, use of physical restraints in institutional settings, and physician awareness of vitamin d deficiency.
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A mAN oN A mISSIoN:
by John Tyler
reP. roN “DoC” reNuArt, Do
when the united stAtes began its invasion of iraq in 2003, ron “doc” renuart, do, was there and ready for action. A senior medical officer, he was fulfilling a dream he had long before attending medical school. “it was something i wanted for years,” says renuart, speaking from his office in tallahassee. “i always pictured myself as a military doctor.” helping others and making a difference has been a passion of renuart’s for as long as he can remember. “i always felt that i was on a path, pursuing a calling,” he says. this calling has led dr. renuart to care for thousands of patients, serve in the heart of the war-torn Middle east, and represent the people in district 18 in the halls of Florida’s Capitol. N AtIVe Flo r ID I A N
Born in coral gables, renuart is a fifth-generation Floridian who remains both proud of and true to his heritage. a zoology major at the university of Florida, he minored in Florida history, completing a senior thesis on george Booker, Md, the first physician to serve in alachua county. after graduation, renuart pursued his medical education at the noVa southeastern university college of osteopathic Medicine. He specialized in internal medicine, and soon after receiving his degree, renuart followed his desire to serve his country and joined the Florida army national guard in 1990. He moved to Jacksonville to complete his residency at the university of Florida Health science center, and it did not take long for renuart to decide to put down roots. He soon began his medical practice in nearby Ponta Vedra. He also became active in local politics and organized medicine, joining the republican club of Ponta Vedra Beach and the Florida osteopathic Medical association (FoMa). although he did not know it at the time, both of these interests would play a significant role in years to come. despite years of active involvement, renuart did not run for public office. Then, following the events of sept. 11, 2001, his life and career went in a whole new direction. mAN oF hoNor
in March of 2003, the united states, with support from great Britain and other european nations, began an invasion of iraq. dr.
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renuart, serving as field surgeon, was among the first wave of troops to enter the conflict. “We were welcomed as liberators,” he remembers. “it was certainly a challenge, but a good time nonetheless. The insurgency had not yet begun.” during a brief return to Florida in 2004, renuart was invited by the late rep. don davis from Jacksonville to present a framed Florida state flag on the floor of the Florida House of representatives. Today, a similar flag hangs in renuart’s capitol office. “it was a true honor,” he says. Throughout his medical career, renuart had traveled to Tallahassee to discuss matters of health care. However, this was his first experience standing on the House floor. later that year, renuart returned to iraq for a second tour of duty, this time serving as chief medical officer. in this new role, he and another officer were responsible for caring for more than 5,000 u.s. troops.
in particular – a couple of young boys – who would change his life forever. “one boy was brought in and he was blue in color, symptomatic of a heart defect,” remembers renuart. “While we were examining him, another boy was brought in who was just as blue as the first.” Both required surgery, which was unavailable in the immediate region. looking for options, renuart sent emails home and soon received a package from his wife, Jackie. The package contained information from the Patrons of the Hearts, a nonprofit organization that provides funding for children with complex heart defects to travel to Florida to receive medical treatment. renuart jumped at the opportunity. after renault pleaded the case for the boys, Patrons of the Hearts accepted both and promptly flew them into Jacksonville. “it was a miracle,” says renuart. “They came to the united states blue and went home healthy and pink.” Pu b l I C S e rVA N t
even with this awesome responsibility, renuart felt dutybound to give back to his present community and help those in need. Throughout his last two tours in the Middle east, renuart visited schools and provided care to children and families in afghan villages. He remembers two patients
after three tours of duty, renuart returned home and focused on his medical practice. Following years of military service and more than a decade in local politics, renuart found himself restless for a new challenge – the Florida legislature. However, living in Florida’s well-established district 18, renuart knew the odds were against him. despite this, he recognized that he held a distinct, personal advantage — the bond between a physician and his patients. “over the years, i realized that i’d seen more than 10,000 patients in the area,” says renuart. “People in the community not only knew me, but knew me as a physician, not a politician.”
Thank You The Florida Medical Association & FMA PAC thanks the following Hospital Medical Staffs for their generous contributions this election cycle:
Fawcett memorial hospital
Palms west hospital
Florida orthopaedic Institute
Peace river
holy Cross hospital
Seven rivers medical Center
Palms of Pasadena
Venice regional medical Center
Together, we’re making Florida a friendlier place for physicians to practice medicine.
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Facing two formidable and experienced candidates, one of whom was married to the popular mayor of nearby neptune Beach, renuart made a commitment to himself. “i made a promise to myself that none of the other candidates would outwork me,” renuart says. renuart lived up to his word, devoting several hours to his campaign each day after work. after joining the Florida Medical association (FMa), renuart became friends with edward s. Homan, Md, a long-time FMa member,
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orthopedic surgeon, and representative of Florida House district 60. Homan helped renuart learn the ropes. He also shared powerful political computer software, which allowed renuart to research the demographics within his district. armed with this knowledge, renuart began going door to door. The race tested his resolve. There were 28 local debates and countless television commercials, billboards, and even banners flown over nFl games. still, renuart persevered and ultimately prevailed. in 2008, he was elected to the Florida House. ForwArD thINker
as a freshman legislator, renuart’s focus is on health care and creating positive solutions for physicians and their patients. “We have to improve care statewide,” he says. “our physician workforce is dwindling, so there is a tremendous need to keep and attract physicians to
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as he fights to protect and improve medicine in the halls of the capitol, renuart will never forget his roots in organized medicine. “organizations like the FMa and FoMa are representing the physicians in the trenches, the ones struggling every day,” he says. “They stand up for individual doctors in a way that no one else can.” as the debate for health care reform builds steam, renuart hopes to increase cooperation among decision makers to ensure the greatest access and highest quality of care for patients. after years of service to his patients, his state, and his country, the physicians of Florida have reason to believe that he can get the job done. “if we can get everyone – the agencies, the hospitals, and the physicians – on the same page,” renuart says, “then i know we will succeed.”
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Florida.” To this end, renuart will continue to pursue greater opportunities for medical students and graduates, including an increased number of state residency slots. He also will remain vigilant in the battle to make Florida’s Medicaid program more efficient and equitable.
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lIVeS oF SerVICe legACIeS
oF INSPIrAtIoN
by John Tyler
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every physiCiAn hAs A story. when the great ones pass away, their stories live on among those they have touched, serving to inspire generations of physicians and patients. henry d. Mcintosh, Md, Alvin e. smith, Md, and harold g. norman, Md, led distinguished yet vastly different lives. however, the heart of their stories is universal. these men devoted their lives and their careers to the service of others, giving more of themselves than anyone could have asked. As the physicians of Florida face growing challenges, these stories stand as testament to what can be achieved and what can be overcome.
henry d. Mcintosh, Md 1921-2008
d during the second World War, the men who parachuted into german-occupied France in the cover of night had every reason to fear for their lives. survival required bravery, strength of character, and a single-minded focus on completing the mission. as a member of the office of strategic services, predecessor to the central intelligence agency, a Henry Mcintosh successfully completed dangerous and daring missions, working with american and British soldiers to organize resistance fighters behind enemy lines. dr. Mcintosh not only survived, but retired from his military service bearing the silver star, the French croix de guerre, and an iron will to get the job done. germany surrendered, and as europe began rebuilding itself, Mcintosh returned home to pursue his medical degree
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from the university of Pennsylvania Medical school. When it came time to select a specialty, Mcintosh made his decision for deeply personal reasons. His first child, Henry Mcintosh, Jr., ultimately succumbed to a lifelong battle with congenital heart disease. determined to take on all medical matters of the heart, Mcintosh chose cardiology and began what would become one of the most distinguished and accomplished careers in the field. For two decades, dr. Mcintosh served at duke university Medical center as both a physician and a professor. There he pioneered groundbreaking research and helped establish its cardiac catheterization lab and coronary care unit. during his last four years at duke, dr. Mcintosh served as chief of cardiology until 1970, when he was offered the position as chair of the Medical department at Baylor university. under his guidance and leadership, Baylor continued its rapid growth to prominence. during his time at Baylor, where he established himself as one of the foremost cardiologists in the world, dr. Mcintosh had two of the most memorable experiences of his career. in 1974, Howard Hughes, the eccentric and reclusive billionaire, arrived unconscious and unresponsive at Methodist Hospital in Houston needing immediate emergency care. it was dr. Mcintosh who pronounced Howard Hughes dead, determining that the american legend had passed long before his arrival. Then in 1977, his last year at Baylor, dr. Mcintosh became aware of a program founded by the guatemalan physician, Federico alfaro, Md, which provided free refurbished pacemakers and the necessary implant surgery to indigent patients. This gave dr. Mcintosh an even greater vision – to apply this humanitarian effort on a global scale, providing pacemakers to patients in need all over the world. With help from rotary international, he was able to realize his dream, creating Heartbeat international, which today sets the benchmark for charitable health care. dr. Mcintosh’s single-minded pursuit of excellence also led him to great heights in organized medicine. He became President of the american college of cardiology, which also named him a distinguished fellow in 1982, and received the distinguished achievement award from the american Medical association in 1986. That same year, President ronald reagan presented dr. Mcintosh with a presidential citation for the creation of Heartbeat international. Born and raised in Florida, dr. Mcintosh eventually returned to his home state and continued practicing cardiology at the Watson clinic in lakeland and became involved with the Florida Medical association. it was at the Watson clinic that FMa immediate Past President steven r. West, Md, met dr.
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Mcintosh for the first time. dr. West immediately recognized dr. Mcintosh’s authoritative presence. “He was a force to be reckoned with,” remembers dr. West. “His goal was to make Florida’s patients the healthiest in the country and he pursued it to the full extent of his power.” dr. West fondly remembers a trip to Tallahassee with the american Heart association to lobby against smoking in public places. “dr. Mcintosh made it very clear to those legislators,” says dr. West, “that if they opposed the ban on smoking, they would ultimately be responsible for the deaths of many.” dr. West laughs, remembering the experience. “They didn’t know who they were dealing with. This man was a war hero.” Today it is difficult to find a public place in Florida where it is legal to smoke indoors. Few people will ever achieve what Henry d. Mcintosh, Md, achieved in 87 years. Yet for anyone who doubts his or her ability to achieve, who questions the power in mere focus and determination, dr. Mcintosh’s life is proof that if it can be dreamed, it can be accomplished.
Alvin E. smith, Md 1931 -2007
Few could have imagined where young alvin smith’s life ultimately would lead. growing up underprivileged and raised by a single mother who worked as a waitress in daytona Beach, smith struggled to find his s ambition. He would often wander, strolling along the windows of downtown shops until he reached one storefront in particular, The angells and Phelps chocolate Factory. Peering through the glass at the rows of handcrafted chocolates he could not afford, alvin smith dreamt of a better life for himself. it was an english teacher at Mainland High school who set him on this path, teaching him the value of education in reaching personal goals. alvin smith would go on to become the first person in his family to attend college and medical school. However, before this, he opted to enlist, serving first in the Florida national guard and later in the united states army. For his service in the Korean War, sergeant smith received the army commendation Medal, awarded to those distinguished by their acts of merit and heroism. dr.
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smith remained active in military service throughout his medical career, ultimately achieving the rank of lieutenant colonel in the army reserves. Following his stint in Korea, smith graduated from the university of Florida and the leonard l. Miller school of Medicine at the university of Miami. after completing an internship in colorado and residency in Hawaii, dr. smith returned to his roots in daytona to begin practice. smith started in private practice, but soon turned his focus toward improving the quality of oncology care in the region. dr. smith envisioned a single facility where cancer patients could receive all of their care, rather than having to travel between multiple locations. His vision and relentless effort ultimately led to the creation of the Herbert d. Kerman regional oncology centers, one of the first facilities of its kind. all along, dr. smith also was active in organized medicine with leadership roles in both the Volusia county Medical society (VcMs) and the Florida Medical association (FMa). While president of the VcMs, dr. smith became acquainted with a future FMa President, carl “rick” lentz, Md. “i was just another loud-mouthed young physician when i got to daytona, unhappy with many of the realities of practicing medicine,” says lentz. soon after meeting, smith pulled lentz aside to offer some personal advice lentz has never forgotten. “He told me to either get involved or shut up,” says lentz, laughing. His colleagues might call it “infectious enthusiasm,” an inability to be deterred from what is right. nevertheless, it was dogged principles that led dr. smith to become one of the FMa’s most important leaders, one who was instrumental in the passage of landmark legislation, and was the last to ever give up on an apparent lost cause. “Whatever the cause, if dr. smith felt it was worthy, he fought for it until the end,” says e. russell Jackson, Jr., FMa senior Vice President. “There were so many of these: the nursing shortage, the case against big tobacco to recover medical expenses for Medicaid patients suffering from tobacco-linked illness, and, of course, the creation of a separate department of Health.” sometimes dr. smith’s relentlessness was rewarded. during his presidency, dr. smith worked cooperatively with gov. lawton chiles, the FMa, and other health care advocates in creating a separate Florida department of Health, one of his proudest accomplishments. despite these great successes, it is important to remember a more personal side of dr. smith’s career as a physician. “dad was incredibly intuitive,” says al smith, Jr., dr. smith’s son. “a diagnosis was never just a diagnosis. He spent enough time with his patients to truly understand them. He was practically
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as much a psychologist as he was a physician.” al smith, Jr. is also proud of the deep roots his father set in the daytona area. “He never forgot who he was or where he came from,” says smith. Today al smith, Jr., runs the angell and Phelps café, beside the angell and Phelps chocolate Factory in downtown daytona. He and his brother chuck now run both establishments, which were given to them by their father, who no longer needed to only look through the window. dr. alvin smith purchased angell and Phelps in 1984 and turned it into a successful family business. “dad had a wonderful rags-to-riches story,” says smith, Jr., who hopes to one day chronicle his father’s life in a book. it is certainly a story worth sharing.
harold g. norman, Md 1937-2001
When Harold norman, Md, came to Florida, he did two things: He opened a solo plastic surgery practice in Miami, and he became active in organized medicine. The year was 1966, and Medicare, with its overwhelming bureaucratic implications, had taken effect. despite the elective nature of d his practice, dr. norman felt called to serve as an advocate for all physicians, to help ensure that they, not the politicians, determined the future of health care. Before long, dr. norman developed a strong reputation for leadership. in the dade county Medical association (dcMa), he worked his way up to serving as chair of virtually every committee, often prioritizing his efforts with dcMa above free time. dr. norman ultimately would serve as president in 1985, and then again in 1988, developing a reputation for visiting and speaking at every hospital medical staff meeting in the dade county area. around this time, dr. norman also became involved in the FMa. Traveling to various FMa events and meetings, he and glenn s. Hooper, Md, a medical school friend and also a proud and active member, reconnected. “Things really fell into place,” remembers Hooper. “We got along; our wives got along. We always had a good time.”
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dr. Hooper also remembers traveling with dr. norman to Tallahassee during the legislative session, lobbying hard for the interests of physicians. “always the same battles,” he says, laughing, “The doctors versus the insurance companies.” For years dr. norman passionately rose as a leader within the FMa, eventually becoming Vice speaker of the House of delegates in 1994. unfortunately, that same year he received a diagnosis that would change his life forever. dr. norman was diagnosed with inoperable colon cancer. “it was unexpected,” says Hooper. “He was an incredibly fit man, could bench press 230 pounds, did not eat red meat.” dr. norman’s physician gave a bleak prognosis: three months to live, maybe six with a good response to chemotherapy. after five years, only one in 20 patients with comparable cancer would survive. “Those are pretty good odds,” norman said in response. “i feel sorry for the other 19 people.” His resolve to survive and continue serving the physicians and patients of Florida became iron-clad. dr. norman lived by his personal philosophy, which was, in his own words, “to help as many people as you can – your patients, family, and friends. always fulfill every commitment you make and always trust in god and follow Him.”
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immediately following his surgery, dr. norman set short, intermediate, and long-term goals for himself. These goals revolved around continuing in medicine, his service to the FMa and his church. While undergoing painful cancer treatment, he continued care for patients and climbed the ranks of the FMa, ultimately becoming speaker of the House. norman also began to travel the world, visiting such exotic ports of call as singapore, egypt, and scotland. during the 1998 FMa annual Meeting in orlando, four years after receiving his diagnosis, norman spoke openly for the first time before the House about his ongoing battle with cancer, revealing a deeply personal struggle. Many were moved to tears. That day, dr. norman reminded every person in the room of their own vulnerabilities and their power to overcome them. soon after, the FMa deemed dr. norman “honorary president,” a privilege that had been bestowed only once before in FMa history. despite his prognosis, dr. norman survived his cancer for six years, until he succumbed in 2001. When asked about these remarkable years, as he continued to fight, dr. norman offered one explanation. He said, “god has kept me healthy so i can help as many people as i can.” a man of tremendous faith and perseverance, dr. norman’s legacy lives on, offering hope to those who face seemingly insurmountable odds.
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