mdadvisor fall 2013

VOLUME 6 • ISSUE 4 • FALL 2013

MDADVISOR: A JOURNAL FOR THE NEW JERSEY MEDICAL COMMUNITY

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ELECTION UPDATE:PUTTING YOUR FINGER ON THE PULSE

OF POLICIES, POLITICS AND ISSUES.

SpecialSenate Primary

Medicaid Expansion

Medicare Extension

Medical Marijuana

ACO

Barbara Buono

Chris Christie

Obamacare

Steve Lonegan

Cory Booker

MDA-163 MDAdvisor FALL 13 ONLINE REV_Layout 1 10/2/13 12:29 PM

MDAdvantageDid you know…

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Sponsors and supports the Edward J. Ill Excellence inMedicine Awards® and Scholarship Fund.

Publishes MDAdvisor: A Journal for the New JerseyMedical Community.

Advocates for all New Jersey physicians.

WE PROVIDE VALUEBEYOND INSURANCE.

Want to know more? Visit www.MDAdvantageonline.com

Two Princess Road, Suite 2, Lawrenceville, NJ 08648888-355-5551

MDA-163 MDAdvisor FALL 13 ONLINE REV_Layout 1 10/2/13 12:29 PM

MDADVISOR 1

Welcome to

the Fall is

sue of MDAdviso

r. The Ed

itorial Boa

rd and I a

re

pleased

to bring

you artic

les on cu

rrent top

ics in the

medical co

mmunity,

including

a discus

sion of r

isks asso

ciated wi

th the us

e of EMRs, a

nd the

new stan

dards req

uiring th

at pharm

acists make

increasin

g demands

on physic

ians for

supportin

g docum

entation

before

filling co

ntrolled

substanc

e prescrip

tions.

As we ap

proach th

e annive

rsary of S

uperstorm

Sandy, w

e bring y

ou

two relat

ed article

s. Health

Commissio

ner O’Dow

d report

s on the

State’s e

fforts to

protect t

he health

of our re

sidents t

hrougho

ut Sandy

recovery,

and Gle

nn Mamary p

rovides so

me interes

ting insig

hts into c

risis

preparati

on from a he

althcare f

acility vie

wpoint.

We also br

ing you

the third

part of

our minim

ally inva

sive surg

ery

series, wh

ich this t

ime focuse

s on rob

otic surg

ery. We are

gratefu

l to

Nancy R

omeo, the C

hief Opera

ting Office

r of a lar

ge medic

al practic

e,

for her in

sight int

o how to

conside

r the bes

t structu

re and op

tions

to ensure

the brigh

test futur

e for medic

al practic

es in a ch

allenging

environm

ent (see

page E37

of our on

line editi

on).

And per

haps most i

mportantly

, we incl

ude a dis

cussion

about the

upcoming e

lections

and the h

ot topic

issues in

Trenton.

I encour

age ever

yone to

educate

himself

or herse

lf on the

issues

that impact

the futu

re of he

althcare i

n

New Jers

ey. Remember to get out and

vote on November 5th!

Sincerely

,

Chairman &

CEO

MDAdvant

age

Insuranc

e Company

of New J

ersey

FROM THE DESK OF PATRICIA A.COSTANTE

MDA-163 MDAdvisor FALL 13 ONLINE REV_Layout 1 10/2/13 12:29 PM Page 1

2 MDADVISOR | FALL 2013

RISK

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MDADVISORA Journal for the New Jersey Medical Community

PUBLISHER

PATRICIA A. COSTANTE, FACHEChairman & CEOMDAdvantage Insurance Company of New Jersey

PUBLISHING & BUSINESS STAFF

CATHERINE E. WILLIAMSSenior Vice President MDAdvantage Insurance Company of New Jersey

JANET S. PUROVice President MDAdvantage Insurance Company of New Jersey

THERESA FOY DIGERONIMOCopy Editor

MORBELLI RUSSO & PARTNERS ADVERTISING INC.

EDITORIAL BOARD

EMERGING MEDICAL LEADERS ADVISORY COMMITTEE

PUBLISHED BY MDADVANTAGE INSURANCE COMPANY OF NEW JERSEYTwo Princess Road, Suite 2 Lawrenceville, NJ 08648www.MDAdvantageonline.comPhone: 888-355-5551 • [email protected]

INDEXED IN THE NATIONAL LIBRARY OF MEDICINE’S MEDLINE® DATABASE.

STEVE ADUBATO, PhD RAYMOND H. BATEMANCAROL V. BROWN, PhDPETE CAMMARANODONALD M.CHERVENAK, MDSTUART D. COOK, MD VINCENT A. DEBARI, PhD

GERALD N. GROB, PhDJEREMY S. HIRSCH, MPAPPAUL J. HIRSCH, MDWILLIAM G. HYNCIK, ATCJOHN ZEN JACKSON, Esq.ALAN J. LIPPMAN, MD

ANDREW BUTLER, MDMICHELLE DIAZOREN JOHNSON, MDNEIL KAUSHAL, MDRAYMOND MALAPERO,MD, MPH

JACQUELINE PARKKIRSTEN TANDBERGREGINA YU

Social networking, with its limitless bound-aries, provides enormous opportunities to reachand share educational, marketing and businessinformation. However, this fact poses enormousbenefits and potential risks for providers andmedical professionals. To protect the providerand sensitive information, policies that providesome level of control, boundaries and check-points are required.

All members of the medical community mustremember that the State Board of Medical Exam-iners has the authority to discipline physicians forunprofessional behavior related to inappropriateuse of social media. Examples of improper usageinclude unprofessional posting of pictures orcomments; online breach of patient confiden-tiality; online defamatory remarks about apatient; derogatory or discriminatory remarksabout one’s religion, nationality, age or weight;and online depiction of intoxication.

Physicians must use risk managementstrategies to avoid unanticipated consequencesthat may result from misuse of social media sites.MDAdvantage Risk Management recommendsthat all physicians: • Maintain a professional e-mail separatefrom personal e-mail,

• Maintain a professional relationship withpatients,

• Set boundaries before agreeing to accepte-mail messages from patients, and

• Refrain from e-mailing medical advice ormaking a diagnosis based on informationobtained through e-mail.

Material published in MDAdvisor represents only the opinions of the authors and does not reflect those of the editors, MDAdvantage Holdings, Inc.,MDAdvantage Insurance Company of New Jersey and any affiliated companies (all as “MDAdvantage®”), their directors, officers or employees orthe institutions with which the author is affiliated. Furthermore, no express or implied warranty or any representation of suitability of this published material is made by the editors, MDAdvantage®, their directors, officers or employees or institutions affiliated with the authors.

The appearance of advertising in MDAdvisor is not a guarantee or endorsement of the product or service of the advertiser by MDAdvantage®. If MDAdvantage® ever endorses a product or program, that will be expressly noted.

Letters to the editor are subject to editing and abridgment.

MDAdvisor (ISSN: 1947-3613 (print); ISSN: 1937-0660 (online)) is published by MDAdvantage Insurance Company of New Jersey. Printed in the USA. Subscription price: $48 per year; $14 single copy. Copyright © 2013 by MDAdvantage®. POSTMASTER: Send address changes to MDAdvantage, Two Princess Road, Suite Two, Lawrenceville, NJ 08648.

For advertising opportunities, please contact MDAdvantage at 888-355-5551.

~ Marlene TaftVice President, Risk Management for MDAdvantage


MDADVISOR 3

FALL

201

3 –

CO

NTE

NTS

1 LETTER FROM MDADVANTAGE® CHAIRMAN & CEO PATRICIA A. COSTANTE

4 LEGISLATIVE BRIEF – NEW JERSEY POLITICAL UPDATE: SPECIAL ELECTIONS, GENERAL ELECTIONS AND HOT TOPIC ISSUES IN TRENTON| By Michael Schweder

8 PROTECTING RESIDENTS’ HEALTH DURING SANDY RECOVERY| By Commissioner Mary E. O’Dowd, MPH

11 MINIMALLY INVASIVE ROBOTIC SURGERY: THE GOOD & THE BAD A DISCUSSION WITH DOMENICO SAVATTA, MD| Interviewed by Theresa Foy DiGeronimo

15 CANNABIS FOR CASH ONLY: THE LACK OF INSURANCE COVERAGE AND REIMBURSEMENT FOR MEDICAL MARIJUANA | By John Zen Jackson, Esq., and Katherine Otto, Esq.

18 NEW PHARMACY STANDARDS AND THEIR POTENTIAL EFFECTS ON PATIENT CARE| By Michael J. Schoppmann, Esq., and Guillermo J. Beades, Esq.

21 COURTROOM AS CLASSROOM–TODAY’S LESSON: MEDICAL MALPRACTICE| By Steve Adubato, PhD

24 THE ROAD TO EMR NONCOMPLIANCE AND FRAUD IS PAVED WITH CUT AND PASTE| By Leonardo M. Tamburello, Esq.

31 HURRICANE SANDY UNCOVERS THE VALUE OF IT INVESTMENTS AND CRISIS PREPARATION| By Glenn Mamary

36 SOCIAL MEDIA AND THE MEDICAL COMMUNITY| By Raymond J. Malapero, MD, MPH

ONLINE ARTICLE – VISIT OUR WEBSITE FOR FULL ARTICLE AT:WWW.MDADVANTAGEONLINE.COM/MDADVISOR

E37 AN INTERVIEW WITH NANCY ROMEO, BSN, MPA: A HEALTHCARE EXECUTIVE’S INSIDER VIEW OF HEALTHCARE TODAY| Interviewed by Marlene Taft and Catherine Williams



In this election season, the focus of the New Jersey healthcarecommunity turns to issues that affect the medical professionin this state. Issues include the special Senate election;the Governor’s race; the continuing debate regardingMedicare, the Patient Protection and Affordable Care Act(PPACA), also called Obamacare, and medical marijuana; aswell as three new laws affecting the medical professionrecently signed by Governor Christie.

THE SPECIAL SENATORIAL ELECTION To fill the seat of the late U.S. Senator Frank Lautenberg,

Governor Christie authorized a Special Senate PrimaryElection that was held on August 13 to determine whichDemocrat and Republican will appear on the equallyunprecedented October 16 Special Senate General Electionballot.1 (Until that time, the Governor has appointedAttorney General Jeffrey Chiesa to fill the vacancy.)

During the process, the Democrats challenged thelegality of the special Senate elections in the AppellateCourt. A three-judge panel ruled in the Governor’s favor,stating the “Legislature has delegated broad authority tothe State’s governor to set the election date.”2 The regularState General Election has not been altered and isscheduled for Tuesday, November 5.

On August 13, both parties saw their candidates win bylarge margins. Newark Mayor Cory Booker received morethan 60 percent of the vote to win the Democratic nom-ination for U.S. Senate. Booker beat Congressman FrankPallone, of Monmouth County, Congressman Rush Holt,of Mercer County, and Assembly Speaker Sheila Oliver, ofEssex County. The Republicans displayed their unity byvoting for former Bogota Mayor Steve Lonegan. He talliedmore than 81 percent of the Republican votes. Lonegandefeated Somerset County physician Alieta Eck to win thenomination.3

Booker and Lonegan hold opposing views on many

issues–the largest being their views on Obamacare.Mayor Booker is ideologically in step with PresidentObama, stating it is “a vital step in the right direction…[it]has already begun to provide millions of Americans withaccess to quality, affordable health insurance.”4 TheNewark Mayor believes some early benefits have alreadybegun, such as a “prohibition on denying coverage dueto preexisting conditions and enhanced access to freepreventative services, such as blood pressure screeningsand mammograms.”4

In direct contrast to Booker’s stance, Lonegan stronglybelieves the “PPACA should be repealed in its entirety.This is a complex pile of regulations and mandatesthat is incomprehensible in its scope and unintendedconsequences. It’s time to start from scratch.”4

Lonegan and Booker face off against each other onOctober 16, only 20 days before the Governor is up forreelection on November 5.

THE RACE FOR GOVERNORGovernor Christie is challenged by his Democrat

opponent, the former Majority Leader of the New JerseySenate, State Senator Barbara Buono (LD18). Since therace began, Senator Buono has been fighting an uphillbattle; she has consistently been trailing GovernorChristie by at least 2-1 in weekly political polls, andshe has struggled to raise campaign funds comparable toGovernor Christie’s record-breaking fundraising totals.5

Senator Buono opposes Christie’s decision to holdthe October 16 Special Senate Election. She communicatedher views through social media saying that the specialelection “serves as a reminder that [Christie] chose towaste $12 million on an extra election in October.”6 ManyNew Jersey races will be won or lost by how a candidatecan relate to the public on many of the issues dis-cussed. Voter turnout will play a larger role in this year’s

NEW JERSEY POLITICAL UPDATE:

By Michael Schweder

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Special Elections, General Elections and Hot Topic Issues in Trenton


MDADVISOR 5

political scene than usual, and Governor Christie is hopefuland confident of a strong showing.

OBAMACARE AND MEDICAIDObamacare and Medicaid expansion are extremely

important issues in New Jersey, and all candidates andNew Jersey voters should pay close attention to theimplications arising from these rules and regulations.

At the same time that Governor Christie has decidedto “expand eligibility for the program under the 2010Affordable Care Act,”7 a recent study reported in thejournal Health Affairs has determined that New Jerseyhas the “nation’s lowest percentage of doctors whoaccept Medicaid patients…54 percent of New Jerseyprimary care doctors didn’t take new Medicaid patientsin 2011 and 2012, well above the national average of33 percent.”8

Some speculate about various reasons for this problem,such as high administrative costs and relatively lowsalaries of primary care physicians compared to specialists,difficulty in finding another doctor to join a practice andthe fact that the higher payment rates for Medicaid areset to expire at the end of 2014. Under the current pay-ment system, doctors are receiving “the same paymentsfor Medicaid patients as they receive from the higher-paying Medicare program. In New Jersey, the increase inMedicaid payments is 109 percent.”7 If these rates arelowered at the end of 2014, doctors may be hesitant toaccept new Medicaid patients, or possibly even to hirestaff to support additional patients.

Many of these factors have brought Senator JosephVitale’s (LD19) bill, S-2354, back into the fold and wouldallow advance practice nurses (APNs) to prescribe med-ication without a formal agreement or joint protocol witha consulting physician. This could lead to APNs openingup their own practices to meet the growing demand ofMedicaid patients. This bill is unlikely to be signed by theGovernor, as the issue is controversial.

The rules and regulation of the Medicare extensionalmost penalized New Jersey for being a high-densitystate. This rule pertained only to New Jersey and RhodeIsland. “In the other 48 states, some hospitals in metro-politan areas receive bonus Medicare payments to com-pensate them for being compared with high-income rurallocales.”9 Since 2005, extensions have been put in

place to include New Jersey and Rhode Island in thesepayments, but were set to expire at the end of the year.Through savvy legislation and lobbying, New Jerseyreceived the extension that would “provide $29 millionfor 25 state hospitals. The New Jersey Hospital Association(NJHA) said the 25 hospitals would receive an additional$44 million in inpatient payments and $13 million in out-patient payments.”9

The Medicaid expansion is new to New Jersey, and withit can come innovative thinking and collaborative partnershipscentered on reducing redundancy and costs. For example,in mid-August, the state’s largest insurance plan, HorizonBlue Cross Blue Shield of New Jersey, and the state’slargest healthcare delivery system, Barnabas Health,announced a partnership to create an accountable careorganization (ACO). The purpose of an ACO is to bringabout the “growth of the new approach to healthcare deliveryin which insurers pay providers to better coordinate care inorder to reduce unnecessary tests and treatments whileaiming to have no drop-off in the quality of care.”10

Additionally, numerous other ACO initiatives are ongoingthroughout New Jersey.

MEDICAL MARIJUANA Governor Christie has set the regulations of the medical

marijuana law that was first signed by then-Governor JonCorzine. However, this program, which contradicts thefederal law on this issue, has hit hurdles since the firstNew Jersey medical marijuana center in Montclairbegan registering patients more than a year ago. Thatspecific center experienced temporary closures duringthe summer in 2013, to allow for time to build up a sur-plus of quality product. That and many other setbackshave proved frustrating for eligible patients. However,two approved centers are preparing to open, one in EggHarbor Township and one in Woodbridge.11

“a recent study reported in the journal Health Affairs has

determined that New Jersey has the “nation’s lowest

percentage of doctors who accept Medicaid patients…

54 percent of New Jersey primary care doctors didn’t

take new Medicaid patients in 2011 and 2012”



NEW HEALTH-RELATED LAWS IN NEW JERSEY Assembly Bill No. 2390: This bill, sponsored by

Assemblywoman Valerie Vainieri Huttle (LD37), Assembly-man John Burzichelli (LD3), Assemblyman Troy Singleton(LD7) and Assemblyman Craig Coughlin (LD19), “prohibitsdiscrimination against potential organ transplant recipienton basis of mental or physical disability.”12 This piece oflegislation passed unanimously through all phases of theNew Jersey government process.

Assembly Bill No. 3432: Governor Christie signed intolaw this bill sponsored by Assemblyman Herb Conaway(LD7), Assemblywoman Pamela Lampitt (LD6), Assembly-woman Nancy Munoz (LD21) and Assemblywoman BettyLouDeCroce (LD26) that will “develop a diabetes action planto reduce the impact of diabetes in the State of NewJersey. The plan is to identify goals and benchmarks relatedto reducing the incidence of diabetes in New Jersey,improving diabetes care and controlling complicationsassociated with diabetes.”13

Senate Bill No. 2227: Signed into law by GovernorChristie, this bill was sponsored by former GovernorRichard Codey (LD27), Senator Sandra Cunningham (LD31),Senator Mila Jacey (LD27) and Assemblyman HerbConaway (LD7); it “requires medical examiner trainingabout sudden unexpected death in epilepsy andrequesting decedent’s medical information and braindonation for research.”14

Michael Schweder is the Director of Government Affairsat Cammarano, Layton & Bombardieri Partners, LLC.

1 New Jersey Department of State. (2013). Election information.www.nj.gov/state/elections/election-information-archive-2013.html.

2 Linhorst, M., & Campisi, A. (2013, June 13). Appellate ruling upholds Christie’s move to schedule special Senate contest before election day. The Record. www.northjersey.com/news/Apellate_ruling_upholds_Christies_move_to_schedule_special_Senate_contest_before_Election_Day.html?page=all.

3 Hernandez, R. (2013, August 13). Booker coasts in primary:‘Make me your senator,’ he tells New Jersey. The New YorkTimes. www.nytimes.com/2013/08/14/nyregion/new-jersey-senate-primary.html?src=mv&_r=0.

4 Star Ledger Staff. (2013, August 13). Election 2013: Wherethe Democratic U.S. Senate candidates stand on the issues.NJ.com. www.nj.com/politics/index.ssf/2013/08/election_2013_where_the_democratic_us_senate_candidates_stand_on_the_issues.html#incart_river.

5 Superville, D. R. (2013, August 8). Poll: Christie has huge lead over Buono in race for N.J. governor. The Record.www.northjersey.com/news/state/elections/Poll_Christie_has_huge_lead_over_Buono_in_governor_race.html.

6 Arco, M. (2013, August 13). Buono votes in special primary,criticizes Christie on timeline. PolitickerNJ. www.politick-ernj.com/back_room/buono-votes-special-primary-criticizes-christie-timeline.

7 Kitchenman, A. (2013, August 8). NJ doctors rank last innation in accepting new Medicaid patients. NJ Spotlight.www.njspotlight.com/stories/13/08/07/new-jersey-doctors-rank-last-in-the-nation-in-rate-of-accepting-new-medicaid-patients.

8 Decker, S. L. (2013). Two-thirds of primary care physiciansaccepted new Medicaid patients in 2011-12: A baseline tomeasure future acceptance rates. Health Affairs, 32(7),1183–1187.

9 Kitchenman, A. (2013, August 6). Feds renew state’sMedicare extension, netting millions for NJ hospitals. NJSpotlight. www.njspotlight.com/stories/13/08/05/feds-renew-state-s-medicare-extension-netting-millions-for-nj-hospitals/.

10 Kitchenman, A. (2013, August 12). Affordable care modelgets big boost with partnership of Horizon, Barnabus. NJSpotlight. www.njspotlight.com/stories/13/08/11/affordable-care-model-gets-big-boost-with-partnership-of-horizon-barnabas/.

11 Kitchenman, A. (2013, August 9). Widespread access tomedical marijuana remains elusive for NJ patients. NJSpot-light. www.njspotlight.com/stories/13/08/08/widespread-access-to-medical-marijuana-remains-elusive-for-nj-patients/.

12 State of New Jersey. (2012, Feb. 6). Assembly No. 2390.www.njleg.state.nj.us/2012/Bills/A2500/2390_I1.HTM.

13 State of New Jersey. (2013, Feb. 7). Assembly No. 3432.www.njleg.state.nj.us/2012/Bills/A3500/3432_S1.HTM.

14 State of New Jersey. (2013, August 7). Senate No. 2227.www.njleg.state.nj.us/bills/BillView.asp.

For more information on medical marijuana in New Jersey,

see “Cannabis for Cash Only: The Lack of Insurance

Coverage and Reimbursement for Medical Marijuana” by

John Zen Jackson, Esq., and Katherine Otto, Esq., on

page 15 of the Fall 2013 issue of MDAdvisor.



New Jersey has made tremendous progress recovering after Superstorm Sandy. Many of our communities havebeen rebuilt and are thriving. However, the effects of the storm are long lasting, and impacted families and individualscontinue to face challenges. The Department of Health’s recovery plan has focused on increasing awareness andproviding resources for social and medical support and environmental health impacts resulting from Sandy. Our agencyhas been working closely with our sister agencies–the Departments of Human Services and Children and Families–ona comprehensive approach. As healthcare providers, you have an opportunity to support these efforts by identifyingthose experiencing health effects related to the storm and ensuring their needs are addressed.

ADDRESSING THE IMPACT OF EMOTIONAL STRESSThe stress of a major cleanup and the financial losses and

additional expenses incurred as a result of the storm aredaunting. Stress disables people, exacerbates disease,precipitates behavioral health issues, leads to substanceabuse and negatively affects relationships and families.The psychological effects can also negatively impact anindividual’s overall health and well-being.

Studies have demonstrated that problems copingwith stress and trauma–such as mental health issues,household discord, substance abuse and domestic violence–increase following disasters. After Hurricane Katrina, NewOrleans households were more likely to break up than similar

U.S. households during the same period.1 There is alsoevidence that child abuse may increase following anatural disaster. In the six-month period after HurricaneFloyd hit North Carolina, there was a fivefold increase in therate of inflicted traumatic brain injury in children under twoyears of age in counties severely affected by the hurricane.Counties that were less affected or not affected at all didnot experience an increase.2

It is important for healthcare practitioners to bewatchful for possible signs and symptoms of the physical,emotional and psychological stress that patients maybe experiencing due to the prolonged, continuingstresses posed by the storm. Patients suffering from the

[ ]Protecting Residents’ HealthDuring Sandy Recovery By Commissioner Mary E. O’Dowd, MPH


MDADVISOR 9

ed counties. New Jersey has a universal screening lawthat requires all children to be tested for lead poisoning atage 1 and age 2 or at least once by age 6. Early diagnosisis critical–it allows children to get early treatment so serioushealth and learning consequences can be avoided.

Another lesson learned from past hurricanes was thatmany people working to repair their homes weren’t takingproper precautions to ensure their safety. Following HurricaneKatrina, the Centers for Disease Control and Preventioninvestigated the extent of mold damage in several areasof Louisiana. This examination determined that 46 percentof inspected homes had visible mold growth, and residentsand remediation workers did not consistently use appropriate

respiratory protection.4

To protect against injury while rebuilding,the Department launched a public aware-ness campaign that includes radio publicservice announcements, op-ed articles andeducational flyers. The campaign messageencouraged people working on recoveryefforts to protect their health by getting atetanus booster and by wearing goggles,

rubber gloves, boots and a respirator. Without taking theseprecautions, residents can harm themselves or exacerbatepreexisting health conditions such as asthma.

To further educate residents, the Department publisheda pamphlet that provides guidelines to residents on how toassess mold and hire contractors to remove mold. More than13,000 copies in English and Spanish have been distributed toresidents. Additionally, with financial support from theDepartment, the Rutgers School of Public Health is providingfree training classes for home and business owners andvolunteers. More than 340 residents have participated inthese classes that have been held throughout the state.

emotional impact of Sandy can be referred to a New Jerseyprogram intended to ensure that those affected by stresshave help during this difficult time. The Hope and Healingprogram offers confidential mental health information andreferrals at 877-294-HELP (4357) (TTY: 877-294-4356). Thephones are answered by trained counselors who can assistanyone experiencing anxiety or depression. Crisis coun-selors have been canvassing the state since Sandy, meetingwith survivors in their neighborhoods, town halls, churchesand anywhere else that people need help dealing with thedamage that goes beyond bricks and mortar. As counselorsmeet with residents, they have found that many are dealingwith feelings of anxiety, fearfulness and sadness. In addition,common physical effects are fatigue andexhaustion. More than 200,000 residentshave been provided information or coun-seling by Hope and Healing staff to date.

Recognizing Environmental Health Issues As part of the state’s recovery efforts,

the Department of Health has been work-ing to prevent and mitigate post-stormenvironmental health problems so these issues do not causeadditional or new challenges to already impacted residents.Individuals and families are at risk from environmentalhealth threats such as mold, lead and asbestos ascommunities repair and rebuild damaged residences andbusinesses. For example, after communities were renovatedand rebuilt following Hurricane Katrina, increased leadlevels were found in soil, posing a potential new leadexposure source and a potential health hazard for children.3

Given that many New Jersey communities are now inthis rebuilding phase, it is imperative that healthcareproviders renew their focus on screening children in affect-

MDAdvantageDid you know…MDAdvantage® is an advocate for allNew Jersey physicians.

That’s value beyond insurance.


There are also classes targeted to public health andbuilding code officials; more than 520 public officials havealready participated in these classes. The brochure andinformation on training classes are available on theDepartment’s Sandy Recovery Resources website atnj.gov/health/er/hurricane_recovery_resources.shtml.

In addition, an increase inmosquito-borne illness such asWest Nile Virus cases is anotherenvironmental health issuethat concerns the New JerseyDepartment of Health. AfterHurricane Katrina, affectedparishes in Louisiana experi-enced an increase in the num-ber of West Nile neuroinvasivedisease (WNND) cases froman average annual number of30 cases in 2002–2005 to 45cases in 2006–despite lossesin population following the

storm. In the affected counties of Mississippi, WNND casesincreased from an annual number of 23 cases in 2002–2005 to55 cases in 2006.5

The Department has launched a West Nile Virus publiceducation campaign that includes radio public serviceannouncements and advertising on NJ Transit trains andbuses to ensure residents know how to protect themselves. In2012, the year after Hurricane Irene, New Jersey had arecord number of cases of West Nile Virus–with 48human cases, including six deaths. Superstorm Sandy creatednew places for mosquitos to breed such as wet debris pilesand depressions left by fallen trees–potentially puttingNew Jersey at risk for another challenging season. We can

reduce the risk of the disease by reminding the public thatthey should wear insect repellent, repair screens, disposeof debris and remove standing water on their property.More information for residents on West Nile Virus can befound at nj.gov/health/cd/westnile/index.shtml.

Joining Together to Increase AwarenessThere are serious health concerns that occur during the

disaster recovery period. It is up to healthcare and publichealth professionals to recognize how people are affectedby disasters and to refer them to appropriate resources forhelp. I am asking healthcare partners throughout the state tojoin the New Jersey Department of Health to increase aware-ness of the health hazards that residents continue to face.Healthcare providers have the ability to assess patients andrefer those who are having difficulty to medical andbehavioral health resources. Recovering after one of themost devastating storms to ever strike our state can beoverwhelming; however, by partnering with healthcareproviders, we can all ensure more residents have theresources they need to better address the physical,emotional and environmental impact of Superstorm Sandy.

Mary E. O’Dowd, MPH, is the Commissioner of theNew Jersey Department of Health.

1 Rendall, M. S. (2011). Household structure and social vulnerability: Lessons from Hurricane Katrina. Santa Monica,CA: RAND Corporation. [Available at www.rand.org/pubs/research_briefs/RB9597 ]

2 World Health Organization, Department of Injuries and Violence Prevention. (2005). Violence and disasters.www.who.int/violence_injury_prevention/publications/violence/violence _disasters.pdf.

3 Raabito, F. A., Iqbal, S., Perry, S., Arroyave, W., & Rice, J.C. (2012, February). Environmental lead after HurricaneKatrina: Implications for future populations. EnvironmentalHealth Perspectives, 120(2), 180–184. [Available atwww.ncbi.nlm.nih.gov/pmc/articles/PMC3279443/]

4 Centers for Disease Control and Prevention. (2006, January20). Health concerns associated with mold in water-damaged homes after Hurricanes Katrina and Rita: NewOrleans Area, Louisiana, October 2005. Morbidity andMortality Weekly Report, 55(2), 41–44. [Available atwww.cdc.gov/mold/pdfs/mmwr55241-44.pdf]

5 Caillouët, K. A., Michaels, S. R., Xiong, X., Foppa, I., & Wesson,D. M. (2008, May). Increase in West Nile neuroinvasive diseaseafter Hurricane Katrina. Emerging Infectious Diseases, 14(5).[Available at wwwnc.cdc.gov/eid/article/14/5/07-1066.htm]

[ ]


“In 2012, the year after Hurricane Irene, New Jersey had

a record number of cases of

West Nile Virus–with 48 human

cases, including six deaths.”


Minimally Invasive Robotic Surgery:

THEGOODTHE BAD*

&

In Part I of this article series, Anthony Quartell, MD, Director of Minimally InvasiveGynecologic Surgery at Saint Barnabas Medical Center, mapped out the benefitsand risks of laparoscopy for a hysterectomy over traditional open surgery.1 In PartII, Steven McCarus, MD, Chief of the Division of Gynecologic Surgery at FloridaHospital Celebration Health, discussed patient safety and informed consent asthey relate specifically to minimally invasive surgery.2 This third and final installmentin the series now discusses the pros and cons of minimally invasive robotic surgery.

Minimally invasive surgery (MIS) is in high demand in various surgical specialtiessuch as urology, gynecology, thoracic surgery, general surgery and head and necksurgery.3 The use specifically of robotic MIS is growing rapidly; the number of these sur-geries jumped from 292,000 to 367,000 between 2011 and 2012–a 26 percent increase.However, many patients are not aware that all MIS procedures are not the same–andtherefore not equal in the benefit/risk ratio. During the period of rapid increase inrobotic surgeries, the number of adverse event reports (AERs) associated with this typeof surgery rose from 211 to 282–a 34 percent increase.4 This increase has moved the U.S.

Interviewed by Theresa Foy DiGeronimo

A Discussion with Domenico Savatta,MD

*This is the third of a three-part series on minimally invasive surgery.

MDADVISOR 11



comes in potency and urinary controlfor prostate cancer surgery.”

Disadvantages and Risks of Robotic Surgery: As withmost surgical procedures, the benefits of robotic surgerycoexist with disadvantages and risks. Various reasonshave been proposed for the 34 percent increase in AERsin robotic surgery.4 It has been noted that “there is nostandardized process for credentialing, teaching, proctoringor obtaining hospital privileges for robotic-assistedsurgery.”6 In fact, the Institute of Medicine and the FDAhave called for a revision of the process by which newdevices enter into practice.7,8

Additionally, there are factors in robotic surgery itselfthat some surgeons find troublesome. As outlined in theMedscape article, “Robotic Surgery: Too Much, Too Soon?,”these include loss of tactile and force feedback (whichincreases the risk of rupturing sutures during knotting), lim-ited placement of trocars required to avoid hitting roboticarms, less aesthetic result due to larger trocars and forcedarch placement compared to laparoscopy, limited accessto the patient due to the cart with the robotic arms and theneed for very specialized physicians and nurses.3

Additionally, Savatta notes the danger of tissue dam-age from an instrument’s heat or electrical current. He cau-tions, “Prior to placing instruments into the surgical field forany minimally invasive surgery, we need to place ports andinsufflate the space with carbon dioxide. Organs and bloodvessels are at risk during this part of the procedure. Therobotic benefit of increased magnification can become anegative here because it reduces the size of the surgicalfield. Therefore, surgical teams need to use exceptionalcare not to injure organs that are not in the surgical field.”

However, Savatta does not feel that the limited surgicalfield is necessarily a disadvantage. “Almost all of thereports of AERs that I have read about,” he notes, “are dueto complications that are inherent to surgery in general orto the procedure being performed. Since the machine is anintegral part of any procedure, it is the interaction betweenthe surgeon and the machine and the skill of the surgeonthat are responsible for the outcome. The risks have to beweighed against advantages that robotic surgery providesand the experience of the surgeon.”

Other reports agree that the AERs associated withrobotic surgery are not necessarily rooted in the procedureitself. It is possible that the jump in AERs is evidence ofimproved data scrutiny. As hospitals develop better over-

“for surgeries that require a high level of precision, such as a prostatectomyfor prostate cancer, the high-definition vision and smaller scissors and other

instruments of robotics can allow for a more precise surgery”

Food and Drug Administration (FDA) to survey surgeons usingthis form of MIS to better understand the risks and benefits.3

While this survey is under way, patients and their physi-cians are left to wonder if the increase in AERs with roboticsurgery indicates a need for caution. To answer this question,it is important to understand exactly how robotic surgery isdifferent from other minimally invasive surgeries and howthose differences affect safety, outcome and cost.

ROBOTIC SURGERY VS. OTHER MINIMALLY INVASIVE SURGERIES

In general, patients understand that robotic surgery issimilar to laparoscopic surgery in that surgical instruments areinserted into small incisions and controlled by the surgeon.However, many do not realize that robotic surgery is quite dif-ferent in that there is a computerized system between thesurgeon and the patient. Domenico Savatta, MD, Chief ofMinimally Invasive and Robotic Adult Urologic Surgery atNewark Beth Israel Medical Center, clarifies the difference forhis patients, noting: “The surgeon drives the robotic systemin the same way that a driver steers a car. The surgeon looksinto a 3D headset that is at the console and uses two joy-sticks and foot pedals to control surgical instruments that therobotic system holds to allow surgical instruments to move ina natural way similar to open surgery. The surgeon controlsthe camera and three additional instruments, and all of theseinstruments are held in place by the robotic system.”

The Advantages of Robotic Surgery: Physicians favoringrobotic surgery over other types of MIS point to multipleadvantages. These include improved dexterity, tremor reduc-tion, movement precision, direct correlation between handmovement and robot movement (rather than mirror-imagemovements of laparoscopy), improved visualization with mag-nification and 3D, scaling down of hand movement to enablemicroscopic procedures, short learning curve and less fatigue.3

Savatta concurs. He notes that although some of thebenefits for the patient are similar to those of other typesof minimally invasive surgery (including smaller incision,less blood loss, shorter hospital stay and quicker return tophysical activity), he acknowledges that “for surgeries thatrequire a high level of precision, such as a prostatectomyfor prostate cancer, the high-definition vision and smallerscissors and other instruments of robotics can allow for amore precise surgery, which can lead to improved out-


MDADVISOR 13

sight systems to enhance collection and reporting of AERs,the numbers will naturally increase.9

Savatta also notes that the length of a physician’slearning curve has to be considered when evaluatingthe safety of a robotic procedure. “The first reportedurological robotic surgery was in 2001. The effect oftraining and the learning curve on safety,” he notes, “isdependent on a surgeon’s skill and experience withsurgery, as well as how comfortable he or she is at usingcontrols to operate instruments.” This comfort level iscertainly tied to experience; when reviewing AER statistics,one must keep in mind that other forms of robotic surgeryhave been in use for only eight years. The rate of AERs islikely to be high when no practitioner has more than eightyears’ experience.10 This can be particularly true given thatthe learning process for robotic surgery is relatively informal;continuing education courses and proctoring sessionsare sponsored by Intuitive Surgical, Inc. (manufacturer ofthe da Vinci Surgical System), but there is no nationalstandard by which an organization credentials surgeonsto perform robotic surgery.11

EVALUATING SAFETYWhatever the cause of the AERs in robotic surgery, the

question remains: Is it safe? “Any operation has risks andcomplications associated with it,” says Savatta. “Manyfactors can decrease or increase the risk of surgery. I haveperformed thousands of cancer surgeries open and laparo-scopic prior to performing robotic surgeries. I convertedeach of the operations I performed with non-roboticsurgery to robotic surgery as I gained more experiencebecause I felt there were advantages with robotic surgeryincluding fewer risks and complications. I do feel thatrobotic surgery is safe in experienced hands.”

The safety comparisons of laparoscopic versus roboticsurgery are of particular interest to physicians. Unfortunately,no randomized trials have compared the different typesof surgery.11 To date, the studies that compare laparoscopyand robotic procedures “are of poor quality and suffer fromsignificant heterogeneity and control bias.”12

Still, Savatta believes that most of the risks associatedwith robotic surgery are similar to those of laparoscopicsurgery. “Laparoscopic surgery provides highly magnifiedimages,” he says, “but only in 2D, which limits depth per-ception. Most instruments move in a counterintuitive way,and it is much more difficult to perform precise surgery. For

complicated surgery, in experienced hands laparoscopic sur-gery is as safe as robotic theoretically, but more difficult toperform, which can lead to poorer outcomes. I explain to mypatients that there is a less than one percent chance of hav-ing a surgical complication with robotic surgery, whichincludes the reported adverse events. I then allow time forpatients to ask specific questions and think about it.”

MISLEADING MARKETING? Although robotic surgeons are careful to explain the risks of

robotic surgery to their patients, there is concern in the medicalcommunity that hospitals market their robotic capabilities inways that mislead patients and drive up medical costs. In a 2011study, investigators reported that of the 41 percent of hospitalsthat use websites to describe their capabilities, 86 percent ofthese sites claimed clinical superiority of robotics, and nonementioned risks.13 In addition, the information disseminatedby hospitals regarding robotic surgery is not evidence-basedand is influenced by the manufacturer.14

Savatta worries about this trend of overhyping roboticsurgery. “I have seen advertisements by both hospitals andphysicians in which I feel that the advantages of roboticsurgery are highlighted while the disadvantages of roboticsurgery are often ignored. Given the learning curve involved inrobotic surgery, the generic claims that hospitals make maynot apply to inexperienced surgical teams. With experience insurgery, the possible risks and complications are better appre-ciated, and surgeons can take steps to minimize these risks inhow they perform the surgery. But the general claim of superi-ority of this surgery is often more opinion than fact. To be fair,I have also read articles and opinions of leading physicians thatdo not perform robotic surgery that highlight the negative fac-tors associated with robotic surgery and not the advantages.”

COST FACTORWhether superior, inferior or equal to other types of sur-

gery, robotic surgery is expensive. The machines themselvescost between $1.5 and $2.2 million, and service contracts runfrom $160,000 to $170,000 per year. According to Savatta,disposable instruments for urological robotic surgery rangefrom $200 to $500, and each procedure can use three to five

“the advantages of robotic surgery are highlighted while the disadvantages of

robotic surgery are often ignored.”



instruments. For other types of surgeries, disposable instru-ments may cost as much as $1,000, with up to eight instrumentsused per procedure. An analysis published in March 2013reported that da Vinci surgeries add incremental costs of 20percent per procedure, which are absorbed by the hospitals.12

Savatta further explains: “The majority of the cost is in thepurchase of the robotic system for the hospital. (The robots Ihave used are usually replaced after about five years.)There is also a yearly maintenance fee and a per-case instru-ment cost. A large variable cost is the procedure time. Oper-ating room costs are expensive; whether a surgeon takes twohours or four hours to perform the same surgery with thesame outcome creates a considerable cost difference. On theother hand, savings in robotic surgeries are seen by shortenedhospital stays and less complications. In the end, in order for ahospital to break even or make money, a high-volume programof efficient surgical teams is needed. I believe that mosthospitals will lose money with robotic surgery.”

The high cost of robotic surgery may also be the result ofthe market monopoly of the da Vinci system–it is the onlyFDA-approved robotic system on the market. Savattabelieves that pricing for robotic systems would be reduced ifthere were more than one company to work with. “Ibelieve, with any technology or industry, having more thanone choice is a benefit for the consumer–or in this case, thehospital, physician and patient. Also, I believe that competingcompanies would offer more support to customers to try togain more business and future business.”

As the medical community continues to monitor andevaluate the pros and cons of robotic surgery, at thistime, it is still unclear whether this surgery has a superioradvantage in most general surgeries. However, as with otherminimally invasive procedures, it is clear that as physiciansgain continued training and experience, the AERs will diminishand the benefits will outweigh the remaining disadvantages.

Domenico Savatta, MD, practices at Urology Group ofNew Jersey in West Orange, New Jersey, and is Chief ofMinimally Invasive and Robotic Adult Urologic Surgeryat Newark Beth Israel Medical Center.

1 Quartell, A. (2013, Spring). Minimally invasive surgery: Thelearning curve for physicians. MDAdvisor, 6(2), 10-14.

2 McCarus, S. (2013, Summer). Minimally invasive surgery:Patient safety & informed consent. MDAdvisor, 6(3), 24–27.

3 Peckham, C., & Schwaitzberg, S. (2013, August 8). Robotic

surgery: Too much, too soon? Medscape Medical News.www.medscape.com/features/slideshow/robotic-surgery.

4 Lowes R. (2013, April 30). FDA investigates robotic surgerysystem after adverse event spike. Medscape Medical News.www.medscape.com/viewarticle/803339.

5 van Dam, P., Hauspy, J., Verkinderen, L., Trinh, X. B., van Dam, P.-J., Van Looy, L., & Dirix, L. (2011). Are costs of robot-assistedsurgery warranted for gynecological procedures? Obstetrics& Gynecology International. www.hindawi.com/journals/ogi/2011/973830/.

6 Parsons, J. K., & Berman, S. (2013, July 15). Making the most ofrobotic-assisted surgery: An interview with Dr. J. Kellogg Par-sons. Medscape. www.medscape.com/viewarticle/807521_1.

7 U.S. Food and Drug Administration. (2012, December 3). FDAannounces public-private partnership to develop regulatoryscience that will speed patient access to new medicaldevice technologies. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330416.htm.

8 Institute of Medicine. (2011). Medical devices and the public’s health: The FDA 510(k) clearance process at 35Years. Washington, DC: The National Academies Press.

9 Colella, J., & Peckham, C. (2013, June 20). Is robotic surgeryworth its price? An interview with Dr. Joseph Colella. Medscape. www.medscape.com/viewarticle/806484_1.

10 Renaud, M., Reibel, N., Zarnegar, R., Germain, A., Quilliot,D., Ayav, A., Bresler, L., & Brunaud, L. (2013, July 7). Multifacto-rial analysis of the learning curve for totally robotic Roux-en-Ygastric bypass for morbid obesity. Obesity Surgery. www.ncbi.nlm.nih.gov/pubmed/?term=Multifactorial+analysis+of+the+learning+curve+for+totally+robotic+Roux-en-Y+gastric+bypass+for+morbid+obesity.

11 Parsons, J. K., & Berman, S. (2013, July 15). Making the most of robotic-assisted surgery: An interview with Dr. J. KelloggParsons. Medscape. www.medscape.com/viewarticle/807521_1.

12 Northland Capital Markets. (2013, March 4). Initiating coverage:Intuitive Surgical, Inc. (ISRG) expectations have a lunartrajectory. [Internal publication].

13 Jin, L. X., Ibrahim, A. M., Newman, N. A., Makarov, D. V., Pronovost, P. J., & Makary, M. A. (2011). Robotic surgery claims on United States hospital websites. Journalfor Healthcare Quality, 2011(33), 48–52.

14 Schiavone, M. B., Kuo, E. C., Naumann, R. W., Burke, W. M.,Lewin, S. N., Neugut, A., Hershman, D. L., Herzog, T. J., &Wright, J. D. (2012). The commercialization of robotic surgery:Unsubstantiated marketing of gynecologic surgery by hospitals.American Journal of Obstetrics & Gynecology, 207(3), 174.


MDADVISOR 15

By John Zen Jackson, Esq., and Katherine Otto, Esq.

CANNABIS FOR CASH ONLY:The Lack of Insurance Coverage andReimbursement for Medical Marijuana

A man suffering frommultiple sclerosis wasconvicted in 2009 ofmanufacturing mari-juana in violation ofNew Jersey statelaw by maintaining a“marijuana grove” athis Somerset Countyhome. At that time,he could not affordprescription medica-

tions for his multiple sclerosis because he had no medicalinsurance. The defendant unsuccessfully advanced a“personal use defense” to the criminal charge of growingmarijuana. Following his conviction, the defendantappealed and argued that 1) his “personal usedefense” was a proper affirmative defense and 2) thepresumption of incarceration with a resulting five-yearprison term and the need for deterrence as part of hissentence following conviction should have been refutedby the then recent enactment of the New Jersey Com-passionate Use Medical Marijuana Act (Act). All of thesecontentions were rejected, with the court commentingthat the Act “has no bearing on the disposition of theappeal.” The conviction was affirmed.1

Even if the defendant had had health coverage ofsome sort, it would have no bearing on his consumptionof marijuana for medicinal purposes. The Act protectsqualified marijuana users from criminal prosecutionunder state law. However, the Act does not entitle a medicalmarijuana user, or his or her prescribing physician, to anyexpectation of coverage or reimbursement for medicalmarijuana use under a health plan or insurance. Despitethe many years of legislative lobbying and efforts tonavigate the risks of criminal prosecution, especially byfederal authorities, this gap in the medical marijuana lawsleaves many for whom the alternative therapy might beof value without access to the potential benefits.

BACKGROUND OF NEW JERSEY AND COLORADO MEDICAL MARIJUANA LAWS

On January 18, 2010, then-Governor Jon Corzinesigned the Act2 on his last day in office. With that, New Jerseybecame the 14th state in the country to adopt a medicalmarijuana program. As of September 2013, a total of 20states and the District of Columbia have adopted variousmedical marijuana programs with some differences inscope and structure.3 In accordance with the Act, theDepartment of Health (DOH) administers the New JerseyMedical Marijuana Program (Program). Various aspectsof the Program, particularly the requirement for an ongoingphysician-patient relationship, have been previously dis-cussed in this journal.4

Colorado was one of the first states to pioneer themovement toward legalizing the use of medical marijuana.Colorado’s first and oldest medical marijuana law tookeffect with the passage of Amendment 20 by Coloradovoters in November 2000. Amendment 20 effectivelylegalized the purchase of limited amounts of medical mar-ijuana by patients and their primary caregivers.5 However,Amendment 20 did not expressly authorize the commercialdistribution of medical marijuana. In the years followingthe passage of Amendment 20, legislators became awareof the need for a state-regulated medical marijuana distri-bution system. During the legislative session of 2010, theColorado Legislature enacted the Colorado MedicalMarijuana Code (Code) that legitimized medical marijuanacenters (dispensaries), subject to the rules and licensingprocedures of counties and municipalities. Administrativeresponsibility is shared between the Colorado Department ofEnvironment and Public Health and the Colorado MedicalMarijuana Enforcement Division. Following passage ofthe Code in summer 2010, the state saw a “green rush ofcannabis entrepreneurs” marked by the registration of1,131 dispensaries and approximately 108,000 medicalmarijuana users with the Colorado Medical MarijuanaEnforcement Division.6

Heavy regulation by the Enforcement Division and



the threat of prosecution under federal law proved to be adifficult hurdle for many entrepreneurs, and as a result, asof March 2013, there were only 675 operational dispensaries,the majority of them operating in Denver and Boulder.6 InNovember 2012, Colorado voters went one step furtherwith the passage of Amendment 64, a constitutionalamendment legalizing personal use of marijuana for adultsat least 21 years of age.7, 8 Similar action was taken in theState of Washington in 2011 to legalize possession andpersonal use of marijuana. The Attorney General of theUnited States has indicated that the Department of Justicewould not challenge these state laws and, on August 29, 2013, issued a memorandum regarding theadministration’s approach to marijuana enforcement.9

Although New Jersey has not taken steps to fully legalizemarijuana like Colorado, the New Jersey Act is similar toColorado’s Medical Marijuana Code in that the Act is

intended to address “debilitating conditions,” which arelisted in the statute as follows:

1. seizure disorder, including epilepsy; intractableskeletal muscular spasticity; or glaucoma, if resistant toconventional medical therapy

2. positive status for human immunodeficiency virus,acquired immune deficiency syndrome or cancer, if severe orchronic pain, severe nausea or vomiting, cachexia or wastingsyndrome results from the condition or its treatment

3. amyotrophic lateral sclerosis, multiple sclerosis,terminal cancer, muscular dystrophy or inflammatory boweldisease, including Crohn’s disease

4. terminal illness, if the physician has determined aprognosis of less than 12 months of life.10

On August 16, 2013, New Jersey’s Governor Christieindicated a willingness to approve an expansion of theProgram in a bill passed by the Legislature on June 10, 2013,if it were revised to meet the stipulations in his conditionalveto. One of the Governor’s recommended revisions wouldallow qualifying children to have access to edible forms ofmedical marijuana.12 The Legislature concurred in therecommended amendments and the revisions were

enacted into law on September 10, 2013.13

The DOH is authorized to approve additional medicalconditions or their treatment as a basis for eligibility forthe Program. However, the Commissioner of Healthhas indicated that no consideration will be given toapproving other medical conditions before the completionof two annual report periods.14

Implementation of the New Jersey CompassionateUse Medical Marijuana Act has faced multiple delays.Initially, the effective date of six months from enactmentin January 2010 was postponed and moved to October 1, 2010, to allow for further consideration by the newGovernor, Chris Christie, and the development of the neces-sary regulations. The DOH proposed regulations beginningin February 2011, which were eventually adopted witha December 2011 effective date.15 The State Board ofMedical Examiners adopted regulations in 2011 to

implement the Act regarding the statutory requirementfor physician licensees to provide certifications andwritten instructions for patients seeking marijuana formedical use.16

As provided in the statute, DOH has established aregistry for qualifying patients or caregivers withapproximately 1,000 persons having registered by thispoint. Similarly, DOH has a listing of registered physiciansparticipating in the program.17 Regarding dispensaries,New Jersey has taken a strict stance on regulatingstate-approved dispensaries, referred to in the statute asalternative treatment centers (ATCs).

At present, DOH has limited its approval of ATC dis-pensaries to those operated by nonprofit entities. Thestatute requires that there be “at least” two ATCs in each ofthe three identified northern, central and southern regionsof the state. The first two centers in a region must be non-profit entities.18 A for-profit center recently sought approvalthrough the DOH and was denied.19 The for-profit centerfiled a lawsuit to compel acceptance of its application, butthe Appellate Division refused to issue such an order.19 Thefirst approved ATC was Greenleaf Compassion Center in

“According to Compassionate Care Foundation CEO Bill Thomas, ‘The Foundation is eager to bring pharmaceutical-

grade medicinal Cannabis to eligible patients in New Jersey. We are particularly excited about

the strain that we are growing that contains high levels of Cannabidiol (CBD).’“


MDADVISOR 17

Montclair, NJ, which opened in December 2012. DOH hasissued approval for two more ATCs: Compassionate CareFoundation in Egg Harbor, opening in the fall of 2013, andCompassionate Care Centers of America Foundation inWoodbridge, opening perhaps late in 2013 or early 2014.20

STATE-AUTHORIZED USE OF MEDICAL MARIJUANAAND INSURANCE COVERAGE

The New Jersey Act explicitly addressed the matter ofreimbursement through government programs or privateinsurance: “Nothing in this act shall be construed to requirea government medical assistance program or private healthinsurer to reimburse a person for costs associated with themedical use of marijuana, or an employer to accommodatethe medical use of marijuana in any workplace.”21

The unavailability of insurance coverage or Medicaid andMedicare reimbursement is consistent across all states. Thisprimarily results from federal law not recognizing a medicinaluse for marijuana. It is still classified by the Drug EnforcementAdministration (DEA) as a Schedule I drug–the same as hero-in. Use of marijuana is still subject to criminal prosecutionunder federal law. It is common for insurance policies to notprovide coverage for criminal acts or violations of statutes.22

In addition, medicinal marijuana does not have FDA

approval. Unless and until the federal government decriminal-izes medicinal marijuana and the FDA approves medicinal use,it is unlikely that any private insurer or government program willcover the cost of medicinal marijuana. An attempt at reclassifi-cation by the DEA was strongly rejected in January 2011.23 Thatposition was challenged with a petition filed with the UnitedStates Court of Appeals for the District of Columbia Circuit. Inan opinion filed on January 22, 2013, the Court upheld theDEA’s decision declining to initiate proceedings to reclassifymarijuana.24 The Court noted the lack of “adequate andwell-controlled studies” that supported the medical use ofmarijuana sufficient to overcome the presumption in favor ofthe federal agency’s action. In July 2013, the petitionersrequested that the United States Supreme Court review thematter. This case is on the Court’s docket for considerationat its September 30, 2013, conference. Disposition of thepetition for certiorari will likely be announced by early October.Since the Supreme Court denies the overwhelming majorityof matters presented to it for review, the reclassificationof marijuana may not be addressed at this time.

Because private insurers and the federal governmentwill not subsidize the cost of medicinal marijuana, partici-pation in the New Jersey Program is costly for patients and

>> Continued on page 34



Physicians nationwide are encountering increasing difficultiesin dealing with the distribution by pharmacies of painmedication and other controlled substances. New standardsrequire that pharmacists make increasingdemands on physicians for supportingdocumentation before filling a prescriptionfor certain controlled substances. In somecases, physicians and their practices arebeing asked to provide information ondiagnosis, ICD-9 codes, expected length oftherapy and previous medications tried andfailed.1 Although pharmacies have good reason toaddress growing national concerns regarding theimproper distribution of controlled substances, newindustry standards have the potential to affect physician-patient relationships and patient care.

PHARMACIES UNILATERALLY CHANGE POLICIESPharmacies are taking it upon themselves to imple-

ment new internal regulations in response to increasedscrutiny by the U.S. Drug Enforcement Administration(DEA), as evidenced by recent court cases, the mostprominent involving pharmaceutical giant Walgreens. OnJune 11, 2013, Walgreens reached an $80 million settlementwith the DEA to resolve pending litigation involving thedistribution of controlled substances by 800 Florida

pharmacies.2 Walgreens, however, is not the onlypharmacy being investigated and prosecuted by theDEA. Last year, a federal judge upheld a similar action

against a drug distribution facility run by CardinalHealth. In that case, investigators

charged Cardinal Health with a“staggeringly high and exponen-tially increasing rate of oxycodonedistribution” by the facility.3

These cases, and others,stem from the DEA’s increasinglyfocused efforts to curtail prescrip-

tion drug abuse throughout theUnited States. Although the DEA has

investigated and prosecuted individual prescribers of pre-scription narcotics and synthetic opiates, the agency is alsonow targeting distributors and dispensers of these prescrip-tion drugs. As part of those efforts, the DEA has contactedpharmacists in various states to remind them of their corre-sponding duty under federal regulations to ensure that eachprescription for a controlled substance is issued for alegitimate medical purpose.4 Pharmacies are also reportingthat DEA agents are regularly visiting their stores withdemands to inspect prescriptions. Unsurprisingly, theagents are focused on opioids and polysubstanceprescribing, as well as large doses and long-term supplies

By Michael J. Schoppmann, Esq., & Guillermo J. Beades, Esq.

NEWPHARMACYSTANDARDS

AND THEIR POTENTIAL EFFECTS ON

Patient CareII


MDADVISOR 19

of drugs. However, rather than promote responsibleprescribing and the appropriate dispensing of controlledsubstances, this constant vigilance by the DEA has resultedin pharmaceutical policies being implemented to shieldpharmacies from liability.

The efforts to protect pharmacies from such action,coupled with an industry-wide over-reaction to the DEA’s increasedinvestigation and prosecution ofthese claims against drug distribu-tions and dispensers (fueled by theunprecedented magnitude of theWalgreens settlement), has causedpharmacies to unilaterally changetheir policies for dispensing con-trolled substances. Physicians andother healthcare providers arereceiving form letters advising of“additional steps” that pharmacistsmust take when verifying certainprescriptions for controlled sub-stances.5 As a consequence, physiciansacross the country are now beingplaced in the position of having todemonstrate the validity of theirprescriptions for certain controlledsubstances in order to comply withthese additional new standards orrisk not having the prescriptionhonored and filled.

PHYSICIANS’ RESPONSE TO A DISTURBING TRENDIn response to this new and disturbing trend, which

many argue undermines patient care and affects a physi-cian’s treatment of his or her patients, physicians must beaware of the potential risks associated with interacting withpharmacies and pharmacists.

Although proper prescribing and dispensing of con-trolled substances must always be encouraged, the newstandards raise additional serious issues related to patientprivacy, administrative burdens and rediagnosing of patientsby pharmacists. Evidenced by the numerous healthcareblogs devoted to these issues, some physicians are evencalling for a boycott of pharmacies instituting such policies.However, with the increasingly widespread implementation

of these policies, such a tactic may be short-sighted andis unlikely to lead to a permanent change or impact theindustry or these issues in any way.

The new policies are rooted in Title 21 of the Code ofFederal Regulations, Section 1306.4, which provides that apharmacist has a corresponding responsibility to ensure

that any prescription for a controlledsubstance that is dispensed is done sofor a legitimate medical purpose.6

Although pharmacists do hold thisresponsibility, the new policies concern-ing the distribution of certain controlledsubstances can potentially interferewith, and be deleterious to, patient care.

In fact, pharmacies themselvesopenly acknowledge that this verifica-tion process may require considerableexpenditures of additional time bydoctors and/or their office staff.Nevertheless, pharmacies faced withoverarching DEA scrutiny argue thatsuch measures are necessary to fulfillthe pharmacist’s role in reducing thepotential abuse of controlled sub-stances.7 It is worthy to note that,notwithstanding the provisions of 21CFR 1364.4, the information currentlybeing requested by pharmacists to fillprescriptions is not required by state orfederal law.

In a recent article in The PharmacistActivist, the author noted: “[I]t is pharmacists who have theprimary responsibilities for the quality and accuracy of themedications and services provided to patients. And it is alsopharmacists who are at greatest risk of losing their reputa-tion, job, license and assets when errors, illegal actions andother inappropriate situations occur when they are ‘incharge.’”8 The author further notes that “executives andmanagers of chain pharmacies have the responsibilitiesfor establishing policies, staffing levels and other procedurespertinent to the operation of the pharmacies, as well as thecompensation and incentives/rewards for pharmacistsand other employees. Although the executives and managersmust share the responsibility and accountability with respectto the operation of a pharmacy, it is pharmacists who have



the primary responsibilityand accountability for

decisions and actions indispensing prescriptions.”8

However, in spite of the pharmacists’ role in deliveringpatient care as reflected in such statements, rather thanpromoting commonsense rules and regulations concerningthe dispensing of controlled substances, pharmacies such asWalgreens are being criticized for implementing a rigidpolicy that is counterintuitive and viewed as not beingsufficiently focused on the best interests of patients.

As Walgreens finds itself at the epicenter of this issue,mainly due to the company’s highly publicized landmark set-tlement with the DEA and recent enactment of a nationwidecontrolled substance dispensing policy, the company is alsoreceiving complaints from physicians as well as medical soci-eties and professional associations. Some healthcare providersare reporting that “pharmacists are challenging and, in manycases, refusing to fill legitimate prescriptions for post-operativenarcotic pain medications such as Vicodin at Walgreenspharmacies.”9 These events have led many doctors to postnotices in their waiting rooms advising patients that they donot work with Walgreens and will not send a patient’sprescriptions to a Walgreens pharmacy. Physicians shouldbe cautious in adopting such tactics as the state licensingauthority and/or the patient’s health plan may not neces-sarily view them as being in the best interests of the patient.

WORK TO CHANGE IMPRACTICAL POLICIES As in this situation, physicians are often at the mercy

of the regulations imposed upon them. However, the firstconsideration of a physician and medical practice must be tohonor their primary obligation–to protect the patient’s bestinterests. If the patient’s pharmacy requires “additionalinformation” before dispensing the prescribed controlledsubstance, then the physician must comply with therequests to the extent permitted by law.

Physicians cannot object, as some have suggested, onthe grounds that privacy laws prohibit them from providingadditional information. State and federal privacy lawsallow physicians to share protected health informationwith another healthcare professional providing care to thepatient.10 If a physician or the patient experiencesdifficulties filling prescriptions for controlledsubstances at any pharmacy, the physician

should consider contacting the state’s pharmacy board todocument the complaint in hopes of prompting changeto what may prove to be impractical and, potentially,unworkable policies and regulations.

Michael J. Schoppmann, Esq., is the ManagingPartner, and Guillermo J. Beades, Esq., is an associateat Kern Augustine Conroy & Schoppmann, P.C., a firmthat specializes in healthcare law.

1 California Medical Association. (2013, May 10). Walgreensrefuses to fill some controlled substance prescriptions withoutadditional information from prescriber. www.cmanet.org/news/detail/?article=walgreens-refuses-to-fill-some-controlled.

2 Walgreens. (2013, June 11). Walgreens issues statementconcerning DEA agreement. http://news.walgreens.com/article_display.cfm?article_id=5753.

3 DEA, Walgreens to square off over pill distribution. (2013,March 20). Portland Press Herald. www.pressherald.com/news/nationworld/dea-walgreens-to-square-off-over-pill-distribution_2013-03-20.html.

4 California Medical Association. (2013, May 13). Fact sheeton changes to Walgreens policy on filling prescriptionsfor controlled substances.

5 North Carolina Medical Society. (2013, June). Sampleletter advising healthcare providers of new policies.www.ncmedsoc.org/blog/index.php/archives/25544.

6 21 CFR 1306.4.

7 Indiana State Medical Association. (2013, April 29). Pharmaciescreating barrier for patients filling controlled substanceprescriptions. www.ismanet.org/news/RSSArticle740.aspx#.UgO2cj3D9Ms.

8 Hussar, D. A. (2013, June). Walgreens challenges CVS inthe race to the bottom – but no individuals are accountable.The Pharmacist Activist. www.pharmacistactivist.com/2013/June_2013.shtml.

9 Sullivan, L. (2012). Doctors claim pharmacy chain Walgreensrefusing to fill pain meds. GA Daily News. www.gadailynews.com/news/144624-doctors-claim-pharmacy-chain-walgreens-refusing-to-fill-pain-meds.html.

10 45 CFR 164.506.


We’ve all seen court trials on TV shows

such as Law and Order and watched court-

room scenes in the movies. But have you

ever wondered what really happens during

a physician’s malpractice trial? In a recent

interview on Caucus: NJ, which airs on PBS

stations Thirteen/WNET and NJTV, Steve

Adubato had the opportunity to sit down

with a number of experts in the New Jersey

medical and legal fields during a program

called “Courtroom as Classroom–Today’s

Lesson: Medical Malpractice.”

These experts were involved in a mock trialheld in March 2013 of an actual malpracticecourt case. This article encapsulates the insightsoffered by these experts to help physiciansunderstand the litigation process as it affects thepractice of medicine.

The experts included: The Honorable Carol A.Ferentz, retired Essex County Superior CourtJudge; Paul Shaaff, Esq., Defense Attorney withOrlovsky, Moody, Schaaff & Conlon; Edward Julie,MD, Director of the Cardiology Center of NorthJersey of Valley Medical Group; and Marlene Taft, RN,Vice President of Risk Management at MDAdvantageInsurance Company of New Jersey.

By Steve Adubato, PhD

MDADVISOR 21


give us an understanding of this expectation from a legalpoint of view?

Shaaff: Standard of care is generally defined as whatthe average physician in a specialty should do in a partic-ular situation. However, the plaintiff has to prove not onlya deviation from the standard of care but also has toestablish proximate cause–meaning that the deviationwas a proximate cause of an injury.

Julie: It is important to note that there is a standardof care in the entire medical community in the UnitedStates. These standards of care are established by fed-eral guidelines and organizations that lay out thefoundations upon which we make reasonable decisionsand the therapeutic implications thereof.

Taft: That is exactly why the strategies used tohelp physicians avoid malpractice cases are not uniqueto specific areas of the country. They are the samethroughout the country, highlighting over and over againthe importance of clear communication among all parties,especially when physicians are supervising mid-levelproviders.

Adubato: It seems there were some communicationproblems between the nurse practitioner and the doctorin this case.

Shaaff: Yes, communication has to be good amongcaregivers, the patient and the patient’s family. Docu-mentation of that communication also has to be goodso that if you get sued, you can give me, as a defenseattorney, something to argue to the jury to persuadethem that you met the standards of care.

Ferentz: Documentation is the next most importantthing to good treatment. Bad results come from not just neg-ligence but also from very good practice. But if it is not doc-umented, the presumption is that it was not done properly.

Shaaff: This particular case reinforced my belief thatit is my job to educate the doctor about what is going tohappen over the course of the litigation process–so whenwe get to the courtroom he or she is not a deer in the head-lights, and he or she knows there is going to be anexpert testifying that the doctor did something wrong.Also, there will probably be an expert testifying that thedoctor made the appropriate judgment in the situation.

Adubato: You can find experts for both sides? Shaaff: Yes, most of the time we can find them.Ferentz: If you can’t find them, the case often settles.

Adubato: The purpose of the mock trial was to bringtogether physicians, lawyers and interested partiesinvolved in a medical malpractice case. To begin, let’s setdown the basics of the case.

Shaaff: The case focused on a woman who came intothe hospital for a hip replacement and postoperatively hadsome cardiac arrhythmia. Her treating cardiologist wascalled in, and he left the management of her care withhis nurse practitioner.

The patient then developed hypotension and abdominalpain. She was found to have suffered a bowel perforationfrom a presumed ischemic event related to her atrial fib-rillation and low blood pressure. She had a complicatedpostoperative medical course, and ultimately, she died.

ANALYSIS OF THE PROBLEMTaft: The problem that brought this case to court

revolved around miscommunication and a delay in acting onclearly significant symptoms. There was communicationamong the nurse practitioner, the patient and the familymember indicating the patient was having pain, but thisinformation was not brought to the attention of the physician.

Adubato: Who was responsible: the nurse or the doctor?Julie: The doctor. The nurse practitioner signs a collab-

orative agreement with the physician who supervises her,ultimately leading to his final responsibility. However, nursepractitioners in this state function very independently interms of evaluating patients, ordering laboratory tests andmaking clinical decisions.

The physician states that he is typically aware of hispatients’ progress on a daily basis by meeting with his nursepractitioner every day and making “verbal rounds” on anypatient he does not physically see, but who is seen by thenurse practitioner. However, the physician alleges that inthis particular case he was not fully informed of thepatient’s day-to-day declining status until day 10, when heordered an abdominal CT scan.

Adubato: Did the doctor do enough in this case?Julie: Probably not because this particular patient’s

vital signs were changing rapidly; there were new signsof ischemic bowel disease. In my opinion, that probablymerited a little closer observation by the physician himself.

Adubato: As I understand it, the legal issue is whetherthe physician met the expected standard of care. Can you



Shaaff: If I have a weak case, chances are I am goingto try to find an expert to defend my client. But if I can’tor I’m having difficulty, I have to try to resolve the case.Many cases can be defended fairly and truthfully becausethe doctor made a judgment call in the best interestof the patient in a difficult situation. This is quite a dif-ferent view of the case than the one of some expert forthe plaintiff who gets to look at the case in the comfort ofhis or her living room on the weekend.

THE ROLE OF DEFENSIVE MEDICINE Adubato: You have touched upon a concern I have

about the way doctors make decisions. It seems that inaddition to doing what is best for the patient, doctorsalso often feel they need to practice defensive medicineto avoid being sued.

Ferentz: The doctors and the general public have tounderstand that as rigorous and unpleasant as litigationis, cases generally fall out the way they should. Doctorsshould just do what they have been trained to do bestand let everyone else

worry later on ifsomething happens. They are always going to

feel badly about being sued, even if there was no neg-ligence on their part, but they can’t do everything.They’re not gods–they’re doctors, and that comes outin the courtroom.

Julie: As a practitioner of cardiology, I need torespectfully disagree with Judge Ferentz. Since I havebeen doing medical malpractice defense work for abouta decade, I am very attuned to how each patient’s case isdeveloping and what I see as the potential exposure andpitfalls from a legal perspective as it is happening. Isometimes find myself overordering tests to rule outunlikely but potentially lethal or destructive diagnoses.

Adubato: Does that drive up the cost of healthcare?Julie: Unfortunately, it dramatically drives up the cost

of healthcare, and from a public health perspective, it isnot the proper way to practice medicine. But I do itbecause I want to make sure my patients get the bestcare, and I do not want to get sued.

Adubato: Will this kind of defensive medicine ensurethat a good, concerned top physician will not get sued?

Julie: No. I think being sued is unavoidable. Remember,a bad outcome does not necessarily mean a deviationfrom the expected standards of care. However, in the

patient’s mind, if the patient ends up prematurelydeceased, or if there is a severe complication, that oftenresults in a phone call to an attorney.

Taft: I agree, but that doesn’t mean there will be anegative outcome for the physician, especially if he or shehas guidance and support.

Shaaff: One of the things we try to educate physiciansabout is what they can do before they are sued to preventthe suit, or at least make their defense better when they aresued. Also, we can advise physicians about what they can doduring the course of the litigation to improve the outcome.

Ferentz: The doctors have to be as interested in thatcourtroom scenario as the plaintiff. Too often, doctors don’tcome to court. Their position is that they have their lawyersto represent them, but that is not good enough. The doctorsmust be in the courtroom. The juries watch them all the time,not just when they are on the witness stand. That jury watchesthat doctor’s body language and demeanor. It is all sub-liminal and important.

Taft: That’s true,and illustrates the purpose of the mock trial: to

educate physicians and our young attorneys about thewhole litigation process. We want them to understand thata knowledgeable and educated physician who has properguidance very early on from our attorneys and claimsrepresentatives will have a case that can be mitigated muchearlier or–even better–may never become a lawsuit at all.

Adubato: I think we can see from this discussion that thethreat of malpractice legal action against doctors has had animpact on the practice and cost of medicine. We have seen inthe details of this sample case how ongoing communicationand detailed documentation are valuable tools in defendinga doctor’s adherence to the standards of care. And we alsohave learned that physicians who reach out immediately forhelp from their insurance carriers can receive valuableguidance from lawyers and risk management experts whounderstand the malpractice litigation process and canhelp to protect a doctor from a charge of negligence. Thisinformation should be in every physician’s toolkit.

Steve Adubato, PhD, is a four-time Emmy Award-winning anchor for Thirteen/WNET (PBS) and NJTV(PBS) and has appeared on the TODAY Show, CNNand FOX as a media and communication expert. He is amotivational speaker and Star-Ledger columnist who haswritten extensively on doctor-patient communication.

MDADVISOR 23


By Leonardo M. Tamburello, Esq.

THE ROAD TO

is paved with

EMR *noncompliance and

FRAUDcutandpaste

* Although the terms “EMR” (electronic medical record) and “EHR” (electronic health record)have sometimes been used interchangeably, EMR will be used in this article to focus thediscussion on the use of electronic rather than physical media to record patient information.The interchange of information, which is the hallmark of EHR, is a topic for another day.



For more than half a century,1 electronic medical records (EMRs)2 have beenheralded as digital replacements for ubiquitous paper charts3 that would allowaccurate recording and sharing of patient information with allied healthcareproviders and patients themselves.4 Despite studies demonstrating that EMRadoption can negatively impact physician performance metrics5 (particularly inspecialties such as family medicine and pediatrics, which require, more than otherspecialties, greater data entry, as opposed to retrieval),6 incentive programs7 haveaccelerated EMR adoption beyond a critical mass with only limited examinationof how electronic records are actually used in the field.

Almost all EMR systems include several forms of input assistance, with themost popular being “copy-and-paste,” use of “macros” (expanded text that istriggered by an abbreviation) and “self-populating” data fields in which, basedon the selection of a checkbox,detailed narrative informationindicating that the work wasdone appears in a note withoutany further action by theauthor.8 In addition, the useof the paste command in anew, blank progress note hasbecome known as a “copyforward.”9 Though copy-and-paste and macros originatedas word processing functions,they are now shared by many types of devices, operating systems and applications,including most EMRs.

When used appropriately, copy-and-paste can be a valuable, time-savingtool. For example, past medical history, which is verified to be unchanged, maybe dealt with in this manner, but should be accompanied by a notation that theinformation was actually reviewed with the patient, is accurate and is up to date.The far more common practice, however, is to simply duplicate a prior note withoutediting, attributing or updating.10 Physician use of copy-and-paste and similarfunctionality, which generates identical or near-identical chart entries, some withlittle or no user action, leads to the creation of so-called “cloned documentation.”11

Such practices form the nucleus of emerging areas of risk management in termsof patient safety, professional liability and EMR compliance.

PATIENT SAFETY AND QUALITY OF CAREBy some accounts, more than half of all information contained in EMRs

has been generated by copy-and-paste.10 In one study, publicly availablesoftware (originally developed to detect academic plagiarism) was used to analyze2,068 intensive-care patient notes, related to 135 different patients and writtenby 62 residents and 11 attending physicians between August 1, 2009, andDecember 31, 2009. Even though the researchers set the copy detection thresholdartificially high to minimize the risk of false positives, they concluded that some82 percent of residents’ notes and 74 percent of attending physicians’ notes

Electronic Medical Records

MDADVISOR 25

X

X

X

“By some accounts, more than half of all informationcontained in EMR records has been generated by

copy-and-paste.10”



contained at least 20 percent copied information. Theserates are comparable to those found in prior studies thatexamined non-intensive care unit (ICU) medical documentationand probably underestimated the extent of copy-and-pastein the sample examined.5

As their usage has spread and their power has grown,EMRs themselves have become insidious vehicles thatstealthily perpetuate and compound misinformation.4

Through repetition, “everything in the EMR becomestrue”12 to the point where thepatient’s chart may lose all narrativecohesion and devolve into a massof “disorganized, irrelevant orerroneous data.”13 These infectedrecords propagate virally withoutcounteragent and lead to resultsthat might seem comical were theynot so serious, such as a notepersisting for days that a “patientneeds drainage, may need OR”after a surgeon had already suc-cessfully drained the abscess; thiswas a case in which an interncopied and pasted a previous notewithout updating it or citing itssource.14

Despite known causalitybetween copy-and-paste errors inmedical records and adverse patient events, the deploy-ment of EMRs continues to proliferate with little scrutinyor oversight.10 Consequently, a new medical term has beenspawned to describe patient harm arising from technology:e-iatrogenesis.15

PROFESSIONAL LIABILITY CONCERNSHIPAA requires that all EMR systems include the ability

to audit and monitor the activities of authorized users.16

As plaintiffs’ medical malpractice counsel learn of theavailability of “information about the information” con-tained in an EMR, this “metadata” has become anincreasingly common target of early discovery.17 Forexample, in cases where the timeliness of a treatment orordering of a diagnostic study is at issue, in addition to hardcopies of medical records, a savvy plaintiff’s counsel mayrequest EMR metadata in an attempt to learn intricatedetails about the client’s treatment that would not be

captured by a traditional paper chart and would almostcertainly remain beyond the recall of witnesses, includinginformation such as how long it took to chart the patientencounter; the location from which the chart entry wasmade; whether and when a note included informationthat had been copied-and-pasted from elsewhere in theEMR; whether a note was edited or added to; preciselywhat time certain diagnostic results became available,whether they were read and, if so, when and by whom;

what other EMR information theuser reviewed in the chartencounter; the amount of timespent reviewing each note; andpotentially dozens of additionalvariables that may be capturedby the EMR system.

These data represent a poten-tial bounty of discovery for savvyattorneys. Thus, in addition toperforming the obvious functionas a repository of information, the EMR system is also a powerfulmonitor of the users who interactwith it.

Often, a plaintiff’s counselrequests medical records toevaluate a potential case beforefiling suit. These requests now

sometimes include EMR metadata within their scope.18

Armed with such detailed information, the plaintiff’s counselcan evaluate and build a “virtual case” against a practitionermuch more efficiently and rapidly than previously possi-ble. Doctors and their defense counsel must be alert tothis possibility and sophisticated enough to discernwhether this information is included in a documentproduction provided by a plaintiff’s counsel in responseto a defense request before the physician’s deposition;the doctor and defense counsel must also be able tointelligently interpret such information for themselves toidentify problems or protective information.

Though a doctor is understandably unlikely toremember the specific encounter or course of treatmentor his or her own manner of documentation in the monthsor years between these occurrences and the filing of aprofessional liability lawsuit concerning them, the persist-ence of metadata concerning minute details about such

Electronic Medical Records XX

“a new medical term has been spawned to describe patient harm

arising from technology: e-iatrogenesis.15”


MDADVISOR 27

events can create formidable litigation challenges. Forexample, the unedited self-populated text that follows an“all systems normal” checkbox can lead to uncomfortablequestioning if it conflicts with the patient’s primarycomplaint on the date of that visit. Similarly, if a physician’snote bears striking similarity to others in the EMR,metadata may confirm that it was not independentlygenerated but is instead a product of the “clinicalplagiarism” that has been widely acknowledged in theliterature for some time.19

This information in the hands of a skilled plaintiff’sadvocate presents unique challenges for a professionalliability defense that must be identified and appreciatedearly in a case. If a doctor gives testimony at the depositionthat unwittingly contradicts the omniscient EMR, a liabilitydefense may be compromised.

From a risk management standpoint, the unre-strained use of cut-and-paste, macros and other similartools in the context of an EMR create significant liabilityconcerns that must be addressed. Risk managementofficers and insurers should consider developing strategiesto minimize this exposure, as outlined below.

EMR-CREATED “CLONED DOCUMENTATION” AND OTHER COMPLIANCE ISSUES

More than one commentator has observed thatprogress notes exist in their modern form repletewith copy-and-paste not to facilitate the transfer ofknowledge but to “pass scrutiny” for purposes of reim-bursement.19, 20 There is a well-documented associationbetween deployment of EMR systems and increasedreimbursement. From 2006 to 2010, analysis shows thathospitals that received government incentives to adoptEMR systems experienced a 47 percent overall increasein higher-level evaluation and management (E/M) codes,which is 15 percent greater than hospitals that did notreceive similar EMR incentive payments.21 Thoughhospitals claim that EMR systems have allowed them tobill more accurately, federal and state regulators, as wellas private insurers such as Aetna and Cigna, have notedthe correlation between EMR adoption and increasedreimbursements. Consequently, payers now appearpoised to closely scrutinize EMR practices, particularlythe use of macros and cut-and-paste,21 which have resultedin so-called “cloned” submissions.

In 2011, the U.S. Department of Health and Human

Services’ Office of the Inspector General’s (OIG) annualWork Plan announced a new targeted search for identicalentries among EMR E/M services based on reports fromMedicare contractors concerning “an increased frequencyof medical records with identical documentation acrossservices.” Consequently, the OIG stated its intention to“review multiple E&M services for the same providers andbeneficiaries to identify… [EMR] documentation practicesassociated with potentially improper payments.”22

In 2012, the Secretary of the U.S. Department of Health andHuman Services and the Attorney General sent a joint letterto five national healthcare provider associations alertingthem to “troubling indications” that providers appear to beusing EMRs to “game the system” through the creation of“false documentation.” This letter warned of increasedreimbursement scrutiny, including the use of “comparativebilling reports” to identify outliers.23 That same month, itwas reported that at least one Medicare contractor hadchided doctors that it would deny payment if “cloneddocumentation” were submitted, while another found that45 of 100 claims from emergency rooms in Texas andOklahoma contained “patterns of overcoding” in “tem-plate-generated records.”21 In addition, the OIG’s 2013Work Plan again cautions providers: “[We intend to]determine the extent to which CMS made potentiallyinappropriate payments for E/M services in 2010 and theconsistency of E/M medical review determinations. We willalso review multiple E/M services for the same providersand beneficiaries to identify electronic health records (EHR)documentation practices associated with potentiallyimproper payments.”24

Separately, the OIG’s investigatory powers have beenstrengthened by regulatory amendments that expand theMedicare overpayment “look back” period from four to tenyears, potentially enabling the federal government to auditand recoup billions in reimbursement already received fromMedicare.25

Regardless of the rationale, from the payer perspective,the inappropriate use of EMR tools that result in identical ornear-identical documentation suggests the submission ofclaims for services that were not actually provided at thetime of the entry, not provided by the author of the entry orprovided by someone (such as a medical student) who maynot bill for particular services. As suggested by the OIG andsome private insurers, in any of these scenarios, a casecan be made that such claims are, at a minimum, improperly

X



thousands of dollars.28 If a pattern of five or more relatedviolations is demonstrated, triple damages are mandatory.29

In addition to the insurer’s damages, the State may seekcivil penalties up to $15,000 per violation, plus its owncosts and counsel fees. Providers may also be referredto licensing boards for disciplinary action, which caninclude further monetary penalties, a period of practicesupervision, billing monitoring and/or license suspensionor outright revocation.30, 31

COMPLIANCE STRATEGIES TO SAFEGUARD AGAINSTEMR “SLOPPY AND PASTE”

As demonstrated by recent OIG pronouncements,users cannot be left to police themselves in the proper useof EMR systems. Multi-leveled strategies directed atincreasing compliant use of EMR input methods aretherefore essential.

From a system architecture perspective, usersshould be forced to encounter “hard stops” at regularintervals when using the EMR that slow down the “clickthrough” process. Compliance officers must gain afirsthand understanding of how their institution’s EMRsystem is used daily and become active participants inestablishing training protocols concerning its proper use.8

Education and mandatory requalification on EMR systemsshould include educating users about risks associatedwith noncompliant data duplication practices, with anemphasis on revenue protection and quality of patientcare. Discussion of the most recent OIG pronouncementsshould be emphasized, regardless of whether theprovider or institution receives direct Medicare orMedicaid reimbursement.

Electronic Medical Records XX

“medical malpractice attorneysmay find a treasure trove of

data collected by EMR systemsthat can be co-opted and

turned against its very users.”

submitted and not reimbursable. In addition to denyingpayment, the submission of such claims may serve as abasis to initiate a wide-ranging audit, which could lead topunitive sanctions against the institution, practice and/orprovider under the federal False Claims Act (FCA) or otherstate compliance laws.

To be liable under the FCA, a defendant must make aclaim or statement that is false or fraudulent that inducesthe government to pay a claim, with knowledge of the falsityof the statement at the time it was made.26 Although the FalseClaims Act applies only to federally funded patient encounters,state counterparts available to any insurer whatsoeverhave become nearly universal. Notably, New Jersey insurerswield a powerful weapon in the form of the Insurance FraudPrevention Act (IFPA) that may be violated when a provider1) presents or causes to be presented any written state-ment in support of a claim for payment, knowing that thestatement contains false or misleading information which ismaterial to the claim, or 2) prepares or makes any writtenstatement intended to be presented to an insurancecompany in support of a claim.27 Treatment notes (or partsthereof) that are duplicated without attribution may runafoul of the IFPA if they give the impression to the payerthat the care documented was not given by the chartingpractitioner at the time. This risk is particularly high whenrecords are serially repeated or “copied forward” acrossseveral different patients.

Compensatory damages awardable for any violationof the IFPA include disgorgement of reimbursementrelated to any tainted claims and the insurance compa-ny’s investigation expenses, court costs and counselfees, which can range into the tens, if not hundreds, of


MDADVISOR 29

Risk management should also identify possible non-compliant users through utilization of the EMR’s internalself-auditing capabilities to determine which usersregularly create duplicate entries in medical records,whether through copy-and-paste, macros or someother functionality. These users can be targeted foradditional education and/or closer internal scrutinybefore their practices compromise patient care or raiseexternal compliance flags.

Clear policies and procedures concerning the properuse of the EMR’s copy-and-paste and similar functionalityshould be established with the polestar that all EMRentries must accurately represent the author’s clinicalwork performed that day.8 If a note relies on, or directly orindirectly references, a prior chart entry (even by the sameauthor), it should do so with clear attribution to the earlierentry by date, time and original author. Clinicians shouldbe encouraged to summarize prior diagnostic testing(i.e., laboratory results, consultation reports, etc.), withproper attribution discussed above rather than wholesalecopying of a report into their note.8

EMR users must be educated and understand thatregardless of the tools used to create their entry, theindividual signing the entry is solely responsible forits content. There should be a strict prohibition on 1) copying notes from one patient chart to another(“copying forward”), 2) copying any medical student’snotes, which are subject to different reimbursementrules than those of plenary licensed physicians, and 3) anycopying associated with the history of the patient’spresent illness.

As a new and evolving medium, the EMR will not bewithout growing pains. Early adopting practitioners haveshunned the traditional storytelling narrative structure infavor of importing heaps of data into their notes.10

Traditional payers, including the government, which haslong touted the promises of EMRs to increase physicianefficiency and reduce costs, have noticed the sharpuptick in reimbursement that accompanies EMRdeployment. Despite some shots across the bow, payershave yet to embark on a wide-ranging systemic crack-down on “cloned documentation.” Within this context,plaintiffs’ medical malpractice attorneys may find a treasuretrove of data collected by EMR systems that can beco-opted and turned against its very users.

Every practitioner who uses an EMR system, or

institution that deploys one, should take affirmativesteps beginning with user education regarding the properuse of shortcuts such as macros and copy-and-paste, orrisk learning a harsh lesson through a billing audit ormalpractice litigation.

Leonardo M. Tamburello, Esq., is Of Counsel at thelaw firm of McElroy, Deutsch, Mulvaney & Carpenter, LLP,in Morristown, New Jersey.

1 Note: For discussion concerning the longstanding unrealizedpromises of EMRs and EHRs, see, e.g., National Assembly onSchool-Based Health Care. (n.d.). History of the electronic medicalrecord. www.nasbhc.org/atf/cf/%7BCD9949F2-2761-42FB-BC7A-CEE165C701D9% 7D/TA_HIT_ history%20of% 20EMR.pdf.

2 Note: Electronic medical records (EMRs) replicate allaspects of paper documentation such as patient history,physician notes, orders, laboratory results, consultationreports and insurance information. In contrast, an elec-tronic health record (EHR) is an EMR with the capability of sharing data with other providers, practices, systems,platforms and devices. See, Garrett, P., & Seidman, J.(2011, January 4). EMR vs. EHR: What is the difference?www.healthit.gov/buzz-blog/electronic-health-and-medical-records/emr-vs-ehr-difference/.

3 Garrett, P., & Seidman, J. (2011, January 4). EMR vs. EHR:What is the difference? www.healthit.gov/buzz-blog/electronic-health-and-medical-records/emr-vs-ehr-difference/.

4 Hartzband, P., & Groopman, J. (2008, April 17). Off therecord: Avoiding pitfalls of going electronic. New EnglandJournal of Medicine, 358, 1656–1658.

5 Thornton, D. (2013, February). Prevalence of copied informationby attendings and residents in critical care progress notes.Critical Care Medicine, 41(2), 382–388.

6 Cerrato, P. (2012, May 7). How to ease EMR frustration. InformationWeek Healthcare. www.informationweek.com/healthcare/electronic-medical-records/how-to-ease-EMR-frustration/232901480.

7 Note: 42 U.S.C. § 300jj–51 requires the U.S. Department ofHealth and Human Services to develop recommendations forinteroperable and secure standards and protocols that facilitateelectronic enrollment of individuals in federal and statehealth and human services programs. Also, the Medicareand Medicaid EMR Incentive Programs provide incentive pay-ments to eligible professionals, eligible hospitals and criticalaccess hospitals (CAHs) as they adopt, implement, upgradeor demonstrate meaningful use of certified EMR technology.Eligible professionals can receive up to $44,000 through theMedicare EMR Incentive Program and up to $63,750 throughthe Medicaid EMR Incentive Program. See, Centers forMedicare & Medicare Services. (2013, June 26 [updated]).

X



The official web site for the Medicare and Medicaid ElectronicHealth Records (EHR) Incentive Programs. www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/ehrincentiveprograms.

8 Association of American Medical Colleges. (2011). ComplianceOfficers’ Forum: Electronic health records in academic medicalcenter. Compliance advisory 2. www.aamc.org/download/253812/data/appropriatedocumentationinanehr.pdf.

9 Note: Though often described as a single function, copy-and-paste is a metaphor for two separate commands, which,when implemented together, permit a user to duplicate text, data, files or objects from one location to another. In the context of EMR usage, users select a section of text, which is then transcribed in a different location when the “paste” command is issued. See, Thornton, D. (2013, February). 383.

10 Hirschtick, R. (2012, July). Sloppy and paste. Web M&M.www.webmm.ahrq.gov/case.aspx?caseID=274.

11 Bresnick, J. (2013, January 9). EHR patient notes: What’s wrong with cloning, anyway? EHR Intelligence.http://ehrintelligence.com/2013/01/09/ehr-patient-notes-what%E2%80%99s-wrong-with-cloning-anyway/.

12 Hirschtick, R. (2006, May). Copy-and-paste. Journal of theAmerican Medical Association, 296(20), 2335–2336.

13 Siegler, E. (2009, June). Copy and paste: A remediable hazardof electronic health records. The American Journal of Medicine,122(6), 495–496. [Available at www.amjmed.com/article/S0002-9343%2809%2900157-0/fulltext]

14 O’Reilly, K. (2013, February 4). EMRs: “Sloppy and paste”endures despite patient safety risk. American Medical News.www.amednews.com/article/20130204/profession/130209993/2/.

15 Thornton, D. (2013, February). 382.

16 45 C.F.R. § 164.312(b).

17 Note: In Aguilar v. Immigration Customs Enforcement, 2008WL 5062700 (S.D.N.Y. Nov. 21, 2008), the court identifiedthree types of metadata: 1) substantive metadata, meaningapplication-based information that may contain modifications,edits or comments, that were not necessarily intended foradversaries to see, 2) system-based metadata, which includeinformation automatically captured by the computer system,such as author, date, time of creation and date of modification,and 3) embedded metadata, which consist of text, numbersand content that is directly input but not necessarily visible onoutput, such as spreadsheet formulas or hyperlinks. Id. at *3-*4. Professional liability concerns regarding EMR metadataare usually focused on the second of these categories,system-based metadata, which HIPAA requires to be capturedand stored.

18 Note: N.J.A.C. 13:35-6.5(c) requires physicians to provide,upon request, “access to professional treatment records…to a patient” or their authorized representative. Thoughthe minimum contents of such records are enumerated, theterm itself is not specifically defined. (See § 6.5(b)(1).) Thisregulation clearly contemplates the copying of “x-rays orother material within a patient record which cannot beroutinely copied or duplicated on a commercial photocopymachine.” (See, § 6.5(c)(4)(ii).) This arguably includesmetadata such as that required by HIPAA to be capturedand maintained.

19 Hartzband, P., & Groopman, J. (2008, April 17). 1656.

20 Thornton, D. (2013, February). 387.

21 Abelson, R. (2012, September 21). Medicare bills rise as records turn electronic. The New York Times.www.nytimes.com/2012/09/22/business/medicare-billing-rises-at-hospitals-with-electronic-records.html?pagewanted=all.

22 U.S. Department of Health and Human Services, Office ofInspector General. (2011). Work Plan Part I, Medicare PartA and Part B. I-14. http://oig.hhs.gov/publications/workplan/2011/WP01-Medicare_A+B.pdf.

23 Sebelius, K., & Holder, E. (2012, September 24). [Letterfrom Secretary of the U.S. Department of Health and HumanServices and the Attorney General U.S. Department of Justice to the Chief Executive Officers of the AmericanHospital Association, Federation of American Hospitals,Association of Academic Health Centers, Association ofAmerican Medical Colleges and National Association of Public Hospitals and Health Systems]. [Available at https://s3.amazonaws.com/s3.documentcloud.org/documents/439406/hhs-doj-health-associations.pdf]

24 U.S. Department of Health and Human Services, Office of Inspector General. (2013). Work Plan Part I: MedicarePart A and Part B. 25. http://oig.hhs.gov/reports-and-publications/archives/workplan/2013/WP01-Mcare_A+B.pdf.

25 42 C.F.R. § 401.305(g).

26 United States v. The Boeing Company, 100 F.Supp. 2d 619, 625-626 (S.D.Oh. 2000).

27 N.J.S.A. 17:33A-4.

28 N.J.S.A. 17:33A-7(a).

29 N.J.S.A. 17:33A-7(b).

30 N.J.S.A. 17:33A-5.

31 N.J.S.A. 45:1-14.

X


MDADVISOR 31

When Hurricane Sandy devastatedthe New Jersey shoreline in October2012, Hunterdon Healthcare wasimpacted by power outages in halfof its physician practice facilities.Fortunately, Hunterdon Healthcare’smanagers had already designed andtested a Business Continuity Planseveral years earlier. This historic storm

gave Hunterdon Healthcare staff the opportunity to test this plan and its informationtechnology (IT) investments in operability that would enable online access toinpatient and outpatient records throughout its facilities.

THE VALUE OF IT INTEROPERABILITYIT interoperability allows multiple computer applications from various vendors the

ability to seamlessly “talk” to each other, thus creating improved workflow and patientsafety. Recognizing that the medical center needed to be more strategic in its approachto interoperability, Hunterdon Healthcare selected an IT vendor partner (InterSystems)to electronically link the medical records of patients across the group’s healthcare system.

Hurricane SandyUncovers the Value of IT Investments

and Crisis Preparation

Hunterdon Healthcare

operates the 60-year-old

Hunterdon Medical Center

and owns 20 physician

practices located in

Hunterdon, Somerset,

Warren and Mercer

counties, as well as health

clinics throughout the

area, the Hunterdon

Regional Cancer Center,

health and wellness centers

and specialty clinics.

By Glenn Mamary

“IT interoperability allows multiple computer applications from various

vendors the ability to seamlessly ‘talk’ to each other, thus

creating improved workflow and patient safety.”



The Facility Managers and ClinicianTeam took charge of the first priority–toidentify space that had power, com-munications and computer networksupport that was suitable for treatingpatients. The team analyzed effectiveflow and the safety of the healthcaredelivery environments that remainedopen. Even though some physicianpractices were tight on space, thesepractices graciously took on staff andpatients from other practices.

The Electronic Medical Record Teamexpeditiously modified security set-tings in all of the information systemsto address the needs of the individualcomputer users. This included changesrequired in the computerized tablesof the “visiting” practice so that appro-priate access to electronic medicalrecords (EMRs) was allowed. Thesecurity changes were all documentedto easily reverse the settings when thepractices returned to normal operation.

The Information Services HardwareTeam configured additional personalcomputers, laptops, printers and otherperipheral equipment in the facilitiesthat were operational. Wireless networkconnectivity coverage was evaluated,and additional wireless routers weredeployed and made operational wherenecessary.

The HIPAA Team consistently providedongoing privacy and security educa-tion. As the office staff members wereexposed to more personal healthinformation during this crisis, theHIPAA Team raised awareness toensure adherence to federal standards.This team also conducted additionalaudits specific to the alternativeoperational mode.

When Hurricane Sandy struck, Hunterdon Healthcare saw the value of this approach as it put its Business ContinuityPlan in place to redistribute healthcare delivery from facilities that were not operational to those that were. Using thecurrent IT platform, patients and their data were mobilized to where appropriate care could be delivered. Redundantcomputer servers were in continuous operation, and the electronic health records of Hunterdon Healthcare patientsremained accessible throughout the storm.

A SPECIFIC MISSION FOR EACH TEAM

The Telecommunications Teamworked with an impromptu teamfrom the members of the CentralBusiness Office to quickly set up a newcall center and then worked withtelephone companies to forward allthe calls from the closed practices tothis call center. When a patient calledhis or her physician’s office, it wastransparent to the patient that thephone call was actually routed to aCentral Business Office.

The Call Center Team was formed tostaff personnel at a newly formedcommunications center location. Thecall center was staffed day and nightby a registrar, physician and nurse, allof whom had online access to Hunter-don Healthcare patient informationand all appointment schedules. Ifpatients had clinical questions,the call center was able to triagethe calls to the nurse or physiciansupporting the call center.

Each Hunterdon Healthcare team had a specific mission and worked tirelessly to meet its goal.

“Redundant computer servers were in continuous operation,

and the electronic health records of Hunterdon Healthcare patients

remained accessible throughout the storm. ”


MDADVISOR 33

MISSION ACCOMPLISHEDIn the aftermath of Hurricane Sandy, patients who

were already stressed while dealing with their own per-sonal issues and losses were able to be treated promptlyand safely at alternative locations. The ability for theseHunterdon patients to see their own providers who hadimmediate access to their medical records, even atalternative locations, was vital to achieving patientsatisfaction. The clinicians had immediate online accessto the following patient-specific information: • Historical and current laboratory and radiology reports• Vital sign documentation• Medical images• Medication profiles and drug interaction checking• Food and drug allergies• Family history• Complete medical histories and problem lists• Progress notes• Immunizations• Inpatient hospitalization patient data• Patient demographics and scheduling information• Patient billing information.

Hunterdon Healthcare’s ability to implement thistype of Business Continuity Plan highlights the value ofIT investments in electronic health records and platformsthat support health information exchange. It is now clearto every team member who rose to the challenge of thisunprecedented storm–Hunterdon’s“Hurricane Heroes”–thatthe seamless patient care would not have beenachievable in a paper world.

LESSONS LEARNED Important lessons were learned that will help

Hunterdon Healthcare in the future, and could also behelpful to others.

For example, we learned that our communicationssystem was inadequate for getting messages to all of ouremployees. Our current expanded system now alsoprovides mapping software so that Hunterdon Healthcare

can see the home residence locations of staff members andknow who lives in each town in the county and surroundingareas. If an issue arises (such as in a particular geographicarea), we can alert the group of employees who would beaffected. This allows us to target messaging to the employeeswho need to know about a given issue at a given time.

WE ALSO LEARNED THAT WE NEED TO EXPECT THE UNEXPECTED

The magnitude of the storm damage and theextreme length of time our off-campus locations werewithout power were not fully anticipated.

Action: Consider getting generators for the larger satellitelocations that historically have the longest outages.The loss of landline phone service, wireless phone

service and Internet service made it extremely difficultfor us to communicate with our employees, medicalstaff and patients.

Action: Collect and maintain cell phone numbers ofemployees and other staff so that texting can be usedto communicate in the absence of voice service.Although we had plenty of diesel fuel to run the

hospital generators, gasoline fuel for our Emergencyand Security vehicles was limited, as was commercialgasoline for our employees and medical staff forcommuting to and from the hospital.

Action: Although we did eventually make arrangementswith a local gas station, we should anticipate this in thefuture and make arrangements ahead of time.In an increasingly electronic medical world, our

Medical Center’s reliance on power has alreadygrown dramatically, and will likely continue to increasein the future.

Action: Planning should start now–including plans forprioritizing systems in the event of a failure of one ormore of our generators.Glenn Mamary is the Vice President and Chief

Information Officer at Hunterdon Healthcare.

“the seamless patient care would not have been achievable in a paper world.”



caregivers. Indeed, it has been described as the “mostexpensive” program in the nation.25 The basic patient andcaregiver registration fee is $200. A reduced fee of $20 isavailable for persons who qualify for Medicaid, FoodStamps, State Temporary Disability or Social SecurityDisability Benefits and Supplemental Security Income.26

The registration is good for a two-year period.27

The costs of regular medical use of marijuana can also behigh. The basic enabling statute requires a “bona fide physi-cian-patient relationship” to certify someone as being a“qualified patient.”28 The implementing regulation of theBoard of Medical Examiners mandates “ongoing responsibil-ity” on the part of the physician, which is defined as having aphysician-patient relationship of at least one year’s duration,assessments on at least four occasions or assuming responsi-bility for care and management after a comprehensive historyand physical examination.29 Adding to the cost of participationin the Program, the regulation requires a reassessment by thephysician at least every three months.30

Projecting the cost to the patient and the probability ofeffective relief is difficult to accomplish. Physician certifi-cates are to set forth the total amount of marijuana that maybe dispensed, but patients are permitted to purchase nomore than two ounces of marijuana from an ATC in a 30-dayperiod.31 At the same time, there is limited guidance onwhat volume of marijuana is effective for conditionswithin the Program’s coverage as well as the controversyregarding the effectiveness of marijuana in controllingsuch problems as chemotherapy-induced nausea.32 DOHregulations require that the ATCs keep records that providethe standards and procedures used to determine the price itcharges and a record of the prices actually charged toeligible patients.33 But each dispensary sets its own prices.Pricing in New Jersey ranges from $400 to $560 for an ounceof marijuana depending on the strain.25 In Colorado, forcomparison, dispensaries charge from $50 to $100 for a quarterounce, with the price depending on the strain.34 Additionally,Marinol (dronabinol), which contains the active ingredientTHIC but is a Schedule III drug, is available by prescription,providing a benchmark for comparison. An average dose ofMarinol is approximately $6.00 more than an averagedose of marijuana but is within the scope of insurance plancoverage35; it is also covered by Medicare.36

CONCLUSIONA number of controlled studies support a medical

use of marijuana,37 but the evidence remains subjectto challenge and the conclusion controversial. It seemsevident that the New Jersey Program provides for highlyregulated access to medicinal marijuana but in a contextthat is inherently preferential to those who can affordthis alternative treatment modality. The cautiousdevelopment of standards for approval of ATCs as wellas guidelines for the use and recognition of abuse ofmedicinal marijuana are grounded in prudent public policy.Nonetheless, the varying costs of medicinal marijuana,completely controlled by either nonprofit or for-profitentities, depending on state law, without the opportunityfor health plan coverage will remain a barrier to fullutilization of a potential resource for relief to patientswith debilitating conditions and terminal illnesses.

The authors are attorneys in the law firm ofMcElroy, Deutsch, Mulvaney & Carpenter, LLP, andmembers of its Health Care Practice Group. JohnZen Jackson is a New Jersey attorney in the firm’sMorristown location. Katherine Otto is a licensedColorado attorney resident in the firm’s GreenwoodVillage office.

1 State v. Wilson, 421 N.J. Super.301, 23 A.3d 489 (App. Div. 2011).

2 Public Law 2009, c. 307 codified at N.J.S.A. 24:61-1 to 24:61-19.

3 Note: The jurisdictions legalizing or authorizing medicalmarijuana are Alaska (1998); Arizona (2010); California(1996); Colorado (2000); Connecticut (2012); Delaware(2011); District of Columbia (2010); Hawaii (2000); Illinois(2013); Maine (1999); Massachusetts (2012); Michigan(2008); Montana (2004); Nevada (2000); New Hampshire(2013); New Jersey (2010); New Mexico (2007); Oregon(1998); Rhode Island (2006); Vermont (2004); and Washington (1998).

4 Alaigh, P. (2011). An ongoing physician-patient relationshipdefines New Jersey’s unique medical marijuana program.MDAdvisor, 4 (1),12–14; Bateman, C. (2010). Medical marijuanain New Jersey. MDAdvisor, 3(2),4–5.

5 Colo. Const. art. XVIII, § 14.

6 Ingold, J. (2013, March 3). Colorado medical-marijuanabusinesses have declined by 40 percent. The Denver Post.www.denverpost.com/news/marijuana/ci_22706453/colorado-medical-marijuana-businesses-have-declined.

7 Colo. Const. art. XVIII, § 16.

8 Note: Arguably, Colorado’s legalization of marijuana for per-

>> Continued from page 17


MDADVISOR 35

25 Livo, S. K. (2013, August 4). Is NJ medical marijuana programmost expensive in the nation? The Star-Ledger.www.nj.com/politics/index.ssf/2013/08/is_nj_medical_marijuana_program_the_most_expensive_in_nation.html.

26 N.J.A.C. 8:64-2.1

27 N.J.A.C. 8:64-3.1.

28 N.J.S.A. 24:6I-3; N.J.A.C. 13:35-7A.2.

29 N.J.A.C. 13:35-7A.2.

30 N.J.A.C. 13:35-7A.5.

31 N.J.A.C. 8:64-2.5.

32 See, e.g., Torado, B. (2012). Cannabinoids in the treatment ofchemotherapy-induced nausea and vomiting. Journal of theNational Comprehensive Cancer Network, 10(4), 487.

33 N.J.A.C. 8:64-9.3(a)(8).

34 Livo, S. K. (2012, Nov.16). Q&A: Medical marijuana in NJ. TheStar-Ledger. www.nj.com/politics/index.ssf/2012/11/qa_medical_marijuana_in_nj.html; Also see: The Clinic: Medical MarijuanaCenter. (2013). The Clinic Capitol Hill’s menu. www.thecliniccolorado.com/menus/caphill-menu; The Dandelion Dispensary. (2012).The Dandelion menu. www.thedandelionco.com/products.

35 ProCon.org. (2008 [updated]). How does the cost of marijuanacompare to the cost of Marinol? Medical Marijuana. http://medicalmarijuana.procon.org/viewanswers.asp?questionID=000091.

36 See, Centers for Medicare & Medicaid Services. (n.d.). Is mytest, item, or service covered? www.medicare.gov/index.html.

37 Abrams, D. I., Jay, C. A., Shade, S. B., Vizoso, H., Reda, H.,Press, S., Kelly, M. E., Rowbotham, M. C., & Petersen, K. L.(2007). Cannabis in painful HIV-associated sensory neuropathy: Arandomized placebo-controlled trial. Neurology, 68, 515–521;Ellis, R. J., Toperoff, W., Vaida, F., van den Brande, G., Gonzales,J., Gouaux, B., Bentley, H., & Atkinson, J. H. (2009).Smoked medicinal cannabis for neuropathic pain in HIV: Arandomized, crossover clinical trial. Neuropsychopharma-cology, 34, 672–680; Wilsey, B., Marcotte, T., Tsodikov, A.,Millman, J., Bentley, H., Gouaux, B., & Fishman, S. A. (2008). Arandomized, placebo-controlled, crossover trial of cannabiscigarettes in neuropathic pain. The Journal of Pain, 9, 506–521; Ware, M. A., Wang, T., Shapiro, S., Robinson, A.,Ducruet, T., Huynh, T., Gamsa, A., Bennett, G. J., & Collet,J. P. (2010). Smoked cannabis for chronic neuropathic pain:A randomized controlled trial. Canadian Medical AssociationJournal, 182, E694–E701; Corey-Bloom, J., Wolfson, T., Gamst,A., Jin, S., Marcotte, T. D., Bentley, H., & Gouaux, B. (2012).Smoked cannabis for spasticity in multiple sclerosis: A randomized, placebo-controlled trial. Canadian MedicalAssociation Journal, 184, 1143–1150.

sonal use renders it more of an “over-the-counter” medicationas opposed to a physician-recommended medication, at leastunder state law.

9 See Perez, E. (2013, Aug. 30). No federal challenge to pot legalization in two states. www.cnn.com/2013/08/29/politics/holder-marijuana-laws/index.html; Cole, J. n.d. Memorandum for all United States attorneys from James M.Cole, deputy attorney general, on subject of guidanceregarding marijuana enforcement. www.justice.gov/iso/opa/resources/3052013829132756857467.pdf.

10 N.J.S.A. 24:61-3.

11 State of New Jersey. (2013). Senate No. 2842. www.njleg.state.nj.us/bills/BillView.asp.

12 State of New Jersey. (2013, August 16). Governor ChrisChristie eases access to New Jersey’s Medical Marijuana Program for sick children. www.state.nj.us/governor/news/news/552013/approved/20130816c.html.

13 Public Law 2013, c. 160.

14 N.J.A.C. 8:64-5.1(a).

15 N.J.A.C. 8:64-1.1 to 64-13-11.

16 N.J.A.C. 13:35-7A-1 to 7A-6.

17 New Jersey Department of Health. (n.d.). New JerseyMedicinal Marijuana Program: Physician registry.www.njmmp.nj.gov/docs/homepage/Physician_Registry.pdf.

18 N.J.S.A. 24:6I-7(a).

19 Natural Medical, Inc. v. New Jersey Department of Health & Sen-ior Services, 428 N.J. Super.259, 52 A.3d 207 (App. Div. 2012).

20 New Jersey Department of Health. (2013). Medicinal MarijuanaProgram: Alternative treatment centers. www.state.nj.us/health/medicalmarijuana/find_atc_pat.shtml.

21 N.J.S.A. 26:61-14.

22 Note: Compare Zurich American Ins. Co. v. O’Hara RegionalCenter for Rehabilitation, 529 F.3d 916 (10th Cir. 2008)(applyingColorado law) with Hampton Medical Group v. Princeton Insur-ance Co., 366 N.J. Super. 165, 840 A.2d 915 (App. Div. 2004).

23 See generally, U.S. Department of Justice, Drug Enforcement Administration. (2013, April). The DEA positionon marijuana. www.justice.gov/dea/docs/marijuana_position_2011.pdf.

24 Americans for Safe Access v. Drug Enforcement Administration,706 F.3d 438 (D.C. Cir. 2013), rehearing en banc denied,petition for cert. filed, (Docket No. 13-84 July 15, 2013).



policy changes and innumerable other posts can befiltered to suit each of our needs as healthcare providers.Social networking also allows physicians to test theirknowledge by allowing them to sign up for daily quizzes,partake in continuing medical education opportunitiesand join friendly knowledge competitions that pitphysician against physician.

Patients also enjoy the ability to use social network-ing to improve their health. With the ease and availabilityof medical information afforded by the Internet, patientsare better educated about their diseases than everbefore. Patients use some of the same social utilities asphysicians do to receive medical information, but alsohave their own resources. Social networking can connectpatients with similar medical disorders and rare diseases

allowing them to communicate their experiences andlend support. Some networks can also connect patientswith other physicians and researchers allowing differentoptions for diagnostics and treatment. Social networkingalso enables our patients to share their experiences andthoughts about their physicians with our current and futurepatients, thus highlighting the continued importance ofa strong physician-patient relationship.

The use of social media in medicine is continuouslyexpanding, and no doubt, this fluid media environmentwill continue to evolve in the future along with the evolutionof our healthcare system.

Raymond J. Malapero, MD, MPH, is currentlycompleting his internship in Internal Medicine atRutgers-New Jersey Medical School. He will be completinghis residency in Anesthesiology at Harvard-Brighamand Women’s Hospital.

edical technology has been rapidly advancing overthe past decade, driving the improvement of prevention,diagnostics and therapeutics for numerous disease processes.However, the medical advancements powered by technologyare not confined to laboratories, clinical trials and our examrooms. Online social media has changed the face of medicineby allowing free, large-scale networking and informationsharing for our patients, our colleagues and ourselves.Facebook, Twitter, LinkedIn, Google+ and many other socialmedia sites have facilitated the ability to collaborate, educateand interact across our healthcare system.

As physicians, we are expected to be current on theliterature, know the answers to our patients’ questions andcommunicate closely with patients, referring physicians, spe-cialists and researchers. General social media and networking

venues have opened the door to increased communicationand collaboration. Networking sites specific to physicianshave allowed physicians to discuss topics, consult with eachother and collaborate on research, thus improving patientcare. Additionally, the Executive Director of Costs of Care,Neel T. Shah, MD, MPP, shares that his organization “hasused social media to strategically build an engaged audienceand to crowdsource frontline stories from patients, nursesand physicians that illustrate opportunities to improve thevalue of care delivery.” (Crowdsourcing has made a majorcontribution to problem-solving in medicine, and particularlyhealthcare cost savings through contributions of a largegroup through online communication.)

Social media has allowed an additional source of physi-cian education. Daily postings touting the most recentlypublished literature, government and non-governmentwarnings and communications (i.e., FDA, CDC, etc.), public

Proceed with Caution:Experience proves that some level of control, boundaries and checkpoints are necessary to protect client/patient data in the social networking medium. Policies that address the professional use of social media are required to provide necessary protection of the provider and of sensitive information. Even the perception of impropriety can be misused either inadvertently or intentionally to harm a physician’s reputation.

and the Medical CommunitySocial

Post?

By Raymond J. Malapero, MD, MPH 2013 EDWARD J. ILL EXCELLENCE IN MEDICINE SCHOLARSHIP RECIPIENT


MDADVISOR E37

Interviewed by Marlene Taft and Catherine E. Williams

Q&AAn Interview with Nancy Romeo, BSN, MPA:A Healthcare Executive’s Insider View of Healthcare Today

Recently, Nancy Romeo responded to questions posed by Marlene Taft and Catherine Williams,sharing her insights into the challenges and benefits of large group practices.

What are some of the challenges that your practice has been facing in this evolving andheavily regulated healthcare environment?Most pressing are the regulatory issues surrounding the question of whether or not large grouppractices should own various ancillaries. Specifically, for us, the major challenge right now is in

regards to the regulation that allows in-office ancillary exceptions. We are allowed an ancillary cancercenter exception because the center is an extension of our practice with a full-service urology officeright next to the center. We overcame a few local challenges when we proposed opening the center inNew Jersey, but now there is a federal challenge based on the premise that there is overutilization ofmedical treatments in practices where physicians own their own ancillaries.

If you look at the statistics that were released to support the charge of overutilization, however, yousee that the numbers actually reflect a change in what is considered standard treatment for that disease entity. When we look at the number of patients at our practice who had surgery (robotic or

QA

Nancy Romeo, BSN, MPA, is Chief Operating Officer of Delaware Valley Urology, LLC.This large group practice has 10 offices in five counties (Atlantic, Cumberland, Camden, Gloucester and Burlington) as well as a pathology lab and a radiationtherapy cancer treatment center. The staff includes 32 urologists, two radiationoncologists and three nurse practitioners.


E38 MDADVISOR | FALL 2013

How do you address the challenges of aligningthe goals and strategies of the physicians in

your practice?Since the majority of our doctors are partners in thepractice with equal ownership, it is not always easy

to find a solution that will work for everyone. However, generally after much discussion, we are able to comeup with a decision with which the majority can agree. Tohelp that process along, our doctors opted to structurethemselves with a Board and six committees. The com-mittees meet and develop recommendations that aresent to the Board; the Board then decides whether toadvance the recommendations as presented, modifythem, reject them or ask the committee to consideradditional information before they make a decision.The committees include Quality, Finance, New Tech-nology, Information Technology, Compensation andHuman Resources. Additionally, we sometimes form adhoc committees to tackle specific projects or issues inaddition to the standing committees. This structuregives the doctors a voice in all areas of the practice andan opportunity to assist with decision making at adeeper level than the Board is often able to participate.

In such a large practice, how are you able tomaintain a standard level of patient care

among all of the offices and the doctors?Our expectations for compliance are high, and ourQuality Assurance (QA) committee is very

active. They use the American Urological Association(AUA) guidelines and continuously look at how our doc-tors compare. The committee members review charts toidentify specific codes that may fall outside the guidelines,and then conduct further research to determine if differ-ences in the sub-specialty explain the variance, or ifprocess modifications are required. For example, are allof the physicians using the appropriate diagnosiscodes to support the ordering of tests and medica-

open) or who participated in active surveillance, they havenot really changed significantly since before we opened theradiation treatment center. Changes in radiation treatmentsreflect the national average, which includes hospitals,highlighting the change in preferred therapy options asopposed to ownership status.

The physicians find that providing services in an inte-grated care model results in improved patient compliance.In this model, there are fewer patients falling through thecracks, potentially going without treatment or delayingtreatment since they can more easily be tracked. As a result,the medical professionals can improve the likelihood thatpatients seek follow-up care, whether they seek furthermedical attention in or outside the practice. Anotheradvantage of an integrated medical practice is the abilitythrough the electronic health record (EHR) to keep all thepatients’ information in one consolidated record. Our non-physician providers, radiation oncologists and urologists areable to remain in constant contact with each other duringthe course of a patient’s treatment and beyond, which lendsitself to improved coordination of care. Our radiologistoncologist can send a message via the EHR to the urologistletting him or her know what is happening on an ongoing

basis. We make sure that before a patient is dischargedfrom our cancer treatment center, the patient has anappointment to go back to the urologist for short- andlong-term follow-up. This is just one more way we canmake sure the patient is not lost to follow-up. Whenpatients go outside our organization to another entity, wedon’t have that kind of communication, so we don’t knownecessarily when they are done with their treatment oreven what kind of treatment they had. We cannot be surewhen or if they are planning to come back to Delaware Valley Urology (DVU) for follow-up, making it more difficultto manage the patient. Having ancillaries allows patientsto move within the system more easily and timely, whichwe believe is beneficial for the patient and his or her family.

“We make sure that before a patient is discharged from our cancer

treatment center, the patient has an appointment to go back to the

urologist for short- and long-term follow-up. This is just one more

way we can make sure the patient is not lost to follow-up.”

Q

A

Q

A


MDADVISOR E39

will result in even more substantial long-term cuts in ourreimbursement. The way we decided to prepare and stayahead of the demand for more resources and lowerreimbursements was to consolidate offices. When DVUformed, we had 16 offices that have now been replaced witheight offices. Only recently, we expanded our footprint intotwo new counties and added two new offices. As a result ofthe office consolidation, we were able to reduce support staffin the offices, but now there is not much left in the offices interms of excess. Cutting staff at this point would impactservices required to provide the care and support that ourpatients deserve and expect when they walk through ourdoor. At this time, we don’t think we can cut any moreoffices, but we continue to look for other ways to improveefficiency and lower costs.

On October 1, 2013, the International Classifica-tion of Diseases system (ICD) will be updated to

the most current system, ICD-10. How will this affectyour practice?

A lot that has to be done to successfully implementthe ICD-10 in a large group practice such as ours. We

are currently working on a gap analysis that will help us identify where we are, where we need help and where weneed to be. We will need to audit our EMR templates to seeif they will meet the new criteria for documentation. We willalso audit our entire physician population to see if their noteswill meet ICD-10 documentation requirements.

Training staff and physicians will also be required. Weare fortunate that three of our billers took it upon them-selves to sign up for classes to become certified in ICD-10.This will give us expertise that will help with trainingother staff. We are also fortunate that our EMR vendor,Allscripts, is one of a handful of vendors that have completedthe certification process, which is also a requirement.

Keeping up with technology is a challenge in allmedical practices. How does it impact a large

practice such as yours?When it comes to technology, we are most challengedby the question of how to secure all the information

transmitted and stored electronically, given the many newdevices that physicians are using. As much as the doctorslove getting quick text messages, we had to identify andimplement a secure text program so that when the office

tions? The compliance work is not to be punitive, butrather supportive. Case findings are used to educate andtrain physicians on any needed procedural changes. Weare also fortunate to have a full-time Compliance Officerwho has helped us to advance our compliance initiatives.

How can large group practices, such as DVU,remain compliant and keep up with all that is

demanded from medical practices today?It is hard to keep on top of everything going on ina large practice. We are constantly reading, listening

and going to seminars to learn about best practices.We also lean on the AUA and the Large Urology GroupPractice Association (LUGPA) for guidance and support. Afew years ago, we formed a coalition in New Jersey calledthe New Jersey Patient Care and Access Coalition(NJPCAC), which is another source of support andinformation. The relationships we have developedthrough this coalition are also a great resource. We oftenask each other questions and check in on what others aredoing or how they interpret new rules or regulations thatcome down and could affect compliance. I feel like weare in a good place to learn from each other during thistime of major change in the medical community.

Has your practice faced any new challengesregarding Medicare reimbursements? About 47 percent of our patient population isMedicare, so we are strongly affected by Medicare

payment changes. Medicare cuts that we see year afteryear pose a constant challenge for medical practiceslike ours. We experienced an approximate 12 percentdecrease in revenues at our radiation center and about thesame in the office practice. Additionally, the sequester cutanother two percent from revenues. So, we were down14 percent to start the year. Obviously, it is a challenge tofigure out how to make that up, or at least stay even withwhere we were the year before, especially when expensesare not decreasing. We are faced with governmentrequirements such as Meaningful Use and Physician Quality and Reporting System (PQRS) programs, not tomention increased demands for precertification and med-ication pre-authorization, which all take more staff timeand cost money. Not meeting the requirements for thegovernment incentive programs within the next two years

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this step because we were able to save a significantamount of money entering into this type of arrangement,and we continue to see the benefits. The PEO provides allthe typical HR services, such as benefits, life insurance,disability, workers compensation, family medical leaveand oversight of employee issues with management staff.

Does your practice plan to employ physicianextenders? We have two hospital-based nurse practitionersand one office-based nurse practitioner who are

a tremendous help for the physicians. I do believe that youwill see medical practices adding physician extenders inareas where they are established rather than adding newdoctors. The use of physician extenders is an efficient wayto increase patient capacity in the offices and increase theefficiency of physicians in the hospital. Physician extenderscan help to free up physicians to spend more time in theoperating room and can help physicians get back to the office more quickly, benefitting both the patient andthe practice.

We have found that using nurse practitioners at thehospital to make rounds and consult with patients is ben-eficial because, unlike the physician assistants, they canpractice independently in New Jersey, whereas physicianassistants require a physician sign off on all notes. Eventhough we generally have our physicians sign off onnotes and round with nurse practitioners, if needed, thenurse practitioner can sign off on the notes independ-ently, and these visits will be reimbursed.

If you could have your wish answered for newstaff, in what area would you place an employee? I would look to hire ancillary support in the office inthe triage and insurance support department. The

triage staff field daily questions from patients aboutthings such as pain following surgery, requests for medications to treat an acute illness or condition or postoperative questions or concerns patients may have.Except for more serious issues or concerns that come up,the triage staff acts as the liaison between the patient andthe physician passing along messages and orders from thephysician. Allowing the triage staff to answer questionsfrom established protocols reduces the number of returncalls that physicians need to make.

staff were communicating with the doctors about suchthings as consults, emergencies or surgeries, they could stilluse this great technology but in a secure manner. We nowuse a system called Core Text for our doctors and staff.Everyone is starting to get used to communicating throughCore Text. Do they love it? No. It is an extra step for thephysicians, but it is what we have to do. That does not helpus solve the problem of how to securely communicate witheveryone outside the practice, however. How do wecommunicate with referring doctors who do not havesecure systems in place? What about the answering services?How do we protect information when doctors or staffs usea personal phone without the secure application on it?

There is still more to be done. How do we secure iPadsand all the other devices that are coming along? What do wedo about lost computers, phones and iPads? We are workingon all of those issues to try to make sure that we can secureas much as possible, but it is a challenge.

How do you think data analytics are going toimpact practices as we move forward into the

new technology-driven medical environment? We recently bought a data benchmarking programthat extracted all of our data to create a comparative

report. The data we now have is overwhelming, and we nowneed to sort it out and prioritize what areas to focus on first.The information will be beneficial for compliance, financial,billing, contracting and compensation. I am excited abouthaving this data and know it will help us prepare for thefuture and improve our current situation.

Do you have a portal to communicate withyour patients?We do, but we are in the early stage of rolling it out.This will allow our patients to go online and input

their information, retrieve lab and radiology results, makeappointments, request medical records and other basic func-tions. We are also beginning to use the portal for schedulingand communicating with patients about upcoming surgeries.

Do you have a Human Resources Department tohandle staffing?We have outsourced our human resources (HR)function to a professional employer organization

(PEO) and have done this since we formed in 2006. We took

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groups, it is a good strategy to partner with a hospital, espe-cially if they are aligned with only one hospital or health system.At DVU, we work with five different systems and at 11different hospitals. We need autonomy to be able toservice all of our hospitals and health systems. We intend tocontinue as an independent organization, strengtheningour position as leaders in our field and growing our foot-print to remain strong. How this plays out in the futuredepends on what happens with accountable care organ-izations (ACOs) and pay-for-performance initiatives thatare in development now. Will it make sense to have a fullintegration within a large multi-specialty group or willdeveloping a loose network of providers from multiplespecialty areas be more successful? Both may have a placein the future. DVU is not currently looking to become partof an integrated multi-specialty group. There are a numberof large groups in the area, and every group is trying todecide what their future strategy should be. We mayfind working together to be advantageous and arealways open to discussions about what the next stepshould be. That being said, there may be areas where itmakes sense for us to have a strategic partnership withthe hospital, but it will most likely be focused on an individualproduct line.

The other thing we are doing that I believe will help ussurvive as an independent large group is developing andimplementing clinical guidelines that standardize patientcare when appropriate. By doing this, we will be able towork with payers to develop performance-based outcomeincentive opportunities that should benefit the plan, thepatient and the physician.

The fact remains that the future of independent,large group practices is hard to predict. DVU is optimisticthat we are one of the groups that are positioned to suc-ceed no matter what comes down from the governmentor payers.

Marlene Taft is Vice President of Risk Managementat MDAdvantage Insurance Company of New Jersey.Catherine E. Williams is Senior Vice President, BusinessDevelopment and Corporate Secretary, at MDAdvantageInsurance Company of New Jersey.

Data integrity is also an area in need of attention. It’sso easy for a busy office staff to input an incorrectenrollment or identification number, and then the billgets kicked back. For example, we see up to 400patients a day in our Voorhees office, and it is easy tomiss a referral or pre-certification for a visit. Withoutthese, the practice will not get reimbursed for thephysician visit. There was a time when carriers acceptedretroactive referrals and pre-certifications, but thosedays are long gone. The bottom line is that keeping upwith all the new requirements and paperwork is a muchlarger undertaking than it was in the past. However,revenues from everyone continue to decrease, and staffhas to do more with less.

Ultimately, do you think that large grouppractices can remain independent? That is not an easy question. For some, yes, butfor some, the answer will most likely be no. A lot

is going to depend on what happens with some of thechallenges we are now facing. The future of healthcare islooking to help physicians and hospitals become moreefficient so we can reduce costs and improve outcomes.Efficiency is generally achieved at higher levels withvolume, integration and size. If the size of a group and theservices they provide are questioned and changed, thosefactors that help drive efficiency and have the best chanceof improving outcomes may be eliminated. If doctors areforced to give up the large group structure and thesuccessful integrated models of care including ancillaries,patients will be affected, and insurance companies willlose out on the results that integrated models are meantto achieve. Although there is a growing trend for physiciansto be employed by hospitals, many physicians are notinterested in becoming employees of hospitals and wouldnot thrive under that type of an arrangement. For some

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“The fact remains that the future of independent, largegroup practices is hard to predict.”


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