Maryland Physician Magazine November/December 2011 Issue

PhysicianPhysicianNeurological DisordersNew Approaches andNew Treatments

Pain ManagementDiminishing Pain andRestoring Function

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NOVEMBER/DECEMBER 2011 VOLUME 1: ISSUE 4

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12 New Approaches Aid the Understanding& Treatment of Neurological Disorders

16 Diminishing Pain, Restoring FunctionTreat it quickly and effectively for better results

F E A T U R E S

D E P A R T M E N T S

ContentsNovember/December 2011 Volume1: Issue 4

2012 16

Cases | 7 | Pain and Symptom Management through Hospice Palliative Care

Solutions | 8 | Four Key Factors that Could Make or Break a Medical Office Lease

Healthcare IT | 20 | ShouldYou Store EHR Data Onsite or Offsite?

Policy | 25 | Coming Soon: Maryland’s Prescription Drug Monitoring Program (PDMP)

Compliance | 27 | The Anti-Kickback Statute:WhatYou Don't Know Could HurtYou

Heritage | 29 | MHA: Leadership and Advocacy for State Healthcare Providers

Good Deeds | 30 | Gilchrist Hospice Care Making AWorld of Difference

On the Cover: Dr. Rami, co-director of the Minimally Invasive Pituitary and Skull Base Center at GBMC

THIS ISSUE CLOSES OUTthe inaugural year ofMaryland Physician.It was just over a year ago when I firstintroduced to a growing advisory board,the concept of building aMaryland-based physician network with acommitment to achieve the higheststandards of quality patient care builtupon a foundation of a print magazine –Maryland Physician Magazine.I’m very proud of the relevant, engaging and well-written content delivered with

clean and inviting graphic design theMaryland Physician team has delivered in “Volume1”, showcasingMaryland physicians spearheading cutting-edge treatments and deliver-ing practical advice on how to run aMaryland-based practicemost efficiently.We’re wellon our way to growing that network – a network inclusive of leading healthcare subjectmatter experts who have contributed both clinical and practicemanagement focusedcontent in each issue.Over the first year of publication, we’ve celebrated women inmedicine; went beyond

the hype of some orthopedic treatments; spotlighted new cancer treatments and imagingadvances while quite proudly, showcasing yourMaryland healthcare peers. Online,Maryland Physician offers you a searchable archive of treatments; physicians and practicemanagement solutions. Newest to our online content is digital video withMarylandPhysician’s Physician Spotlight.The very first reader message I received after the launch ofMaryland Physicianwas

a request for content focused on painmanagement. Acute, chronic or imagined, painbrings many of your patients into your practice. A cover story exploration of advancesin three very diverse areas in the field of treating neurologic disorders leads into therequested painmanagement feature, focused on new and ancient treatment options.November is celebrated as National Hospice/Palliative CareMonth. As an advocate

for hospice care, I’m raising awareness of the incredible work hospice and palliativecare professionals provide throughoutMaryland. A few of these very special people arerecognized in these following pages and atMaryland Physician Magazine online.Along with input from the variety of specialists on theMaryland Physician advisory

board, we look to you for editorial counsel. How canMaryland Physician help you achievethe highest standards of quality patient care?Wishing you a very happy and healthyNew Year,

Jacquie RothPublisher/Executive [email protected]

4 | WWW.MDPHYSICIANMAG.COM

JACQUIE ROTH, PUBLISHER/EXECUTIVE [email protected]

LINDA HARDER, MANAGING [email protected]

CONTRIBUTING WRITERSAllison EatoughTracy Fitzgerald

CONTRIBUTING PHOTOGRAPHYTracey Brown, Papercamera Photography

www.papercamera.comMark Molesky, Moleskey Photography

www.moleskyphotography.com

DIGITALAndrei Palmer, Digital General Manager

Aertight [email protected]

ADMINISTRATIONGinger Jenkins

Maryland Physician Magazine™ is published bimonthly byMojo Media, LLC. a certified Minority Business Enterprise (MBE).

Mojo Media, LLCPO Box 1663Millersville, MD 21108443-837-6948www.mojomedia.biz

Subscription information: Maryland Physician Magazineis mailed free to Maryland licensed and practicing physiciansand a select audience of Maryland healthcare executivesand stakeholders. Subscriptions are available for the annualcost of $42.00. To be added to the circulation list, call443-837-6948.

Reprints: Reproduction of any contact is strictly prohibitedand protected by copy right laws. To order reprints of articlesor back issues, please call 443-837-6948 or email [email protected].

Maryland Physician Magazine Advisory Board: Anadvisory board comprised of medical practitioners and businessleaders in diverse practice, business and geographic scopesprovides editorial counsel to Maryland Physician. Advisoryboard members include:

JOHN BARRY, M.D.Chesapeake Orthopaedic & Sports Medicine Center

KAREN COUSINS-BROWN, D.O.Maryland General Hospital

HOLLY DAHLMAN, M.D.Greenspring Valley Internal Medicine, LLC

PAUL W. DAVIES, M.D., FACSAdvanced Pain Management

GAUROV DAYAL, M.D.Adventist HealthCare

MICHAEL EPSTEIN, M.D.Digestive Disorders Associates

STACY D. FISHER, M.D.University of Maryland Medical Center

REGINA HAMPTON, M.D. FACSSignature Breast Care

DANILO ESPINOLA, M.D.Advanced Radiology

GENE RANSOM, J.D., CEOMedChi

Although every precaution is taken to ensure accuracy ofpublished materials, Maryland Physician and Mojo Media, LLCcannot be held responsible for opinions expressed or factssupplied by authors and resources.

Green logo here

Call it transformation. A renovation. Or an extreme hospital makeover. But for those who haven’t

experienced the hotel-like comfort of the newly redesigned Herman & Walter Samuelson Breast

Care Center at Northwest Hospital, you will be pleasantly surprised. Led by Dr. Dawn Leonard,

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YES, WE’VE REDESIGNED OUR BREAST CARE CENTER TO FEEL MORE LIKE A FOUR-STAR HOTEL.

NO, YOUR IN-LAWS CAN’T STAY HERE WHEN THEY’RE IN TOWN.

Northwest Hospital is locatedat the corner of Old Court and Liberty Roads.

DISCUSSIONHospice and palliativecare medicine focus on improving thequality of one’s life rather than oncurative medical options, and expert painand symptom management are a largepart of achieving quality of life objectives.Statistics show that, while cancer pain canbe managed well in 90% of patients, it

often is not. Pain management can bechallenging, yet can be tackledsuccessfully with a thorough assessmentof cancer pain, non-cancer pain and non-physical types of pain.

First, the hospice team assessed thecancer pain. Cancer pain can be bony,neuropathic, visceral or intramuscular.The patient had a dull ache in hisshoulders, legs and back that increasedwith ambulation and weight-bearing. Forthe bony pain, the patient was already onan opioid that, while progressivelyincreased to Morphine 75 mg twice daily,was still ineffective. In this case, anNSAID, steroid or both can be used. Westarted him on Decadron 4 mg twicedaily. Within a few days of starting thesteroid, the patient was able to ambulateagain, increase his food intake, andgenerally function better.

His non-cancer pain (arthritis,headaches and constipation) also wasassessed. The patient did have occasionalheadaches that resolved with the steroid. AnNSAID could have been used in lieu of thesteroid. For many hospice patients, non-physical pain, including feelings of anxiety,denial, fear, and hopelessness, can be evenmore important to treat than their physicalpain. The hospice team – including thephysician, nurse, social worker, clergy,volunteer coordinator andmultiplevolunteers – saw the patient and addressedhis fear of aloneness, loss of independenceand denial of his medical condition. Otherpatients in the hospice facility befriendedhim, sharing time and conversation outsideon a wooden deck adorned with beds ofplanted flowers. These types of emotionaland spiritual support, tailored to thepatient’s needs, are important componentsof hospice care that are specificallymandated by federal regulations.

The patient is now ambulatory, eatsregularly, goes out independently at times

with friends and still performs odd jobs,all of which bring him pride, self worth,and a feeling of purposeful living. Thispatient’s case exemplifies how a hospiceteam approach can effectively addressmyriad types of pain and dramaticallyimprove the physical and emotional livesof terminally ill patients. He is also atestament to one of the core precepts ofhospice, namely giving patients the rightto die without pain and with dignity.

As long as this patient lives, he willreceive compassionate care directed atexpert management of his pain,symptoms and a high quality end-of-life.

Hospice is now a significant player inend-of-life care options and statisticsdemonstrate its appeal. The latest usagedata, compiled for 2009 by the NationalHospice and Palliative Care Organization(NHPCO), shows hospice as a steadilygrowing resource for the terminally ill, withan estimated 41.6% of all U.S. deathsoccurring under hospice home care orinpatient services. More than 5,000 hospiceproviders in the country now meet thissteadily growing demand, providing anaverage 69-day service per patient.According to the NHPCO, cancerdiagnoses account for 40.1% of all hospiceadmissions, followed by debilityunspecified (13.1%), heart disease (11.5%),dementia (11.2%), and lung disease (8.2%).Karen Cousins-Brown, D.O., CMD, earned her

Doctor of Osteopathy from the Philadelphia

College of Osteopathic Medicine. She is the

Medical Director at Maryland General Hospital

in Baltimore, Maryland of the Acute Care Unit

for the Elderly and is the Clinical Preceptor for

the Johns Hopkins Geriatric Fellows for the

Unit. In addition, Dr. Cousins-Brown is the

Medical Director for Joseph Richey Hospice in

Baltimore and serves as Long Care Attending

for several nursing facilities in the greater Bal-

timore Metropolitan Area. She can be reached

at [email protected].


Cases

Pain and Symptom Managementthrough Hospice Palliative Care

CASE:A 61-year-old male –homeless, but social andproductive in his community– has a diagnosis of advancednon-small cell lung cancer,failure to thrive, nearobstruction due to superiorvena cava syndrome,debility, and a right-sidednon-malignant pleuraleffusion. Despite receivingchemotherapy with Cisplatinand radiation, he continuedto decline. He decided todiscontinue treatments andsigned onto hospice. Uponhospice admission from alocal hospital, he was takingMSContin 30 mg everyeight hours and Oxycodone10mg every four hoursPRN for pain. He becameprogressively bedbound, atea minimal amount, exhibiteddepression and presentedwith significant, variablepain management issues.What treatment options areavailable for this patient?

Karen Cousins-Brown, D.O., CMD

NE OF THE LARGESTannual expenses of any medical practice isthe cost associated with the space in whichit operates. In today’s recovering economy,the medical office building sector hasrebounded, too, making leasing costs formedical practices an even more importantconsideration, particularly in Marylandwhere real estate costs and cost of livingare higher than in neighboring states.Medical office building sales haveincreased and vacancy rates have begunleveling out from their high in 2009 –making it crucial for physicians andmedical office administrators tounderstand all of the options available tothem when negotiating a new lease.

Medical practices should view theirleases as they would a personal investment.The total lease obligation for a medicalpractice can range from hundreds ofthousands of dollars to millions of dollarsdepending on the size of the space, the rentper square foot and the length of the term.

A medical practice will have only oneopportunity to get it right – at the time theletter of intent and lease are negotiated. Itis, therefore, critical to retain experiencedattorneys and accountants who havesubstantial leasing and related experience.Perhaps more importantly, the medicalpractice will need a leasing broker thatspecializes in leasing medical office spaceand that knows the market in order tonegotiate the best deal possible. Havingthe right team could save the practice asubstantial amount of money over thelease term.

The four most important factors of a newlease (or lease renewal) to consider are:

� Lease Term� Rent� Tenant Improvement Allowance� Security Deposit/Limitations on Risk

1. Lease TermA newmedical practice that is establishingitself can reduce its financial exposure byconsidering a shorter-term lease (5 yearsor less) with one or more renewal optionsthereafter.

A more established medical practicemight consider a longer-term lease (10years or more) with one or more renewaloptions thereafter.

Remember, however, the longer thelease term, the more concessions (forexample, rent abatement, tenantimprovement allowance and free rent) thelandlord is generally willing to consider.

2. RentBase rent is generally dictated by themarket value of the space, which isdetermined by factors such as location,type of building and location of the spacewithin the building. New buildings withmore amenities cost more.

The length of the lease term and rentconcessions granted to the tenant can alsoaffect the base rent.

In today’s market, landlords often willconsider some component of free rent orabated rent for a period of time.

3. Tenant Improvement AllowanceAn important component of any new leaseis the monetary contribution by the land-lord to the build out of a practice’s space(sometimes known as a tenant improvementallowance). The greater the contributionby the landlord, the less money a medicalpractice will be required to pay out ofpocket for construction expenses.

A carefully drafted letter of intent andlease should provide that the tenant bepermitted to use the tenant improvementallowance for hard costs of performingimprovements and soft costs (e.g., architec-tural and engineering fees) of construction.

The lease should also be clear thatthe landlord will pay the contractordirectly (or jointly with the practice) sothat the practice is not required to payconstruction costs prior to beingreimbursed by the landlord.

4. Security Deposit/Limitations on RiskThe amount of the security deposit willmost likely be dictated by the practice’sfinancial strength. If the practice is newor does not have strong financialstatements, the landlord likely willrequire some combination of cash andpersonal guarantee(s).

If a personal guaranty is required, tryto limit the amount of personal liabilityunder the guaranty (in the form of a fixeddollar amount) instead of merely guaran-teeing all obligations under the lease.

The landlord might agree to reducethe cash security deposit over time aslong as the medical practice is not indefault, sometimes referred to as a “burnoff” or a “phased reduction.”

An alternative to providing cash forthe security deposit is a letter of creditissued by a bank, with the landlord as thebeneficiary.While this frees up the practice’scash, letters of credit often entail fees.

Other leasing considerations includeassignment and subleasing rights, defaultand remedy provisions and holdover.Decisions regarding a medical practice’slease (or lease renewal) could have far-reaching implications. Careful considerationmust be given to every aspect of the leasetransaction prior to execution.Reed P. Sexter is Vice President and Senior

Counsel at Shapiro, Lifschitz & Schram, P.C.

where he advises numerous local medical and

dental practices on entity formation, leases,

property acquisitions, partnership agreements

and employment agreements. He can be

reached at [email protected]


Solutions

Four Key Factors that Could Makeor Break a Medical Office Lease

BY REED P. SEXTER

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ANCER PATIENTS SOME-times fear the prospect of a series of long,painful treatments as much as they fear thedisease itself. TrueBeam, a new radiationtherapy treatment that provides pinpointaccuracy with unprecedented ease andspeed, offers them new hope. SinaiHospital’s Alvin & Lois Lapidus CancerInstitute was the first in the region to offerthis advanced linear accelerator.

“It provides a radically differentapproach to treating cancer with image-guided radiotherapy,” observes JeanetteLinder, M.D., chief of RadiationOncology at Sinai Hospital’s Alvin & LoisLapidus Cancer Institute. Along withfellow radiation oncologist CardellaColeman, M.D., she now offers thetreatment to patients diagnosed with mosttypes of cancers. The system can be usedfor all forms of advanced external-beamradiotherapy, including image-guidedradiotherapy (IGRT), intensity-modulatedradiotherapy (IMRT) and stereotacticradiation therapy.

“TrueBeam opens up newpossibilities for treating challenging cases,such as cancers in the lung, breast,abdomen, and head and neck, as well asnearly all cancers that are treatable withradiotherapy,” Dr. Linder says.

The device provides dose deliveryrates that are 40–140% higher than earliergenerations of radiation therapies. As aresult, it improves patient comfort bydramatically reducing the length ofindividual treatments – sometimes to lessthan two minutes.

TrueBeam rotates around the patient

to deliver a prescribed amountof radiation from nearly anyangle. Its sophisticatedtechnology combines imagingand beam delivery to targettumors with sub-millimeteraccuracy, even when the tumor ismoving. It synchronizes beamdelivery with respiration andother corporeal movements toattack lung and other challengingtumors. Over 100,000 data pointsare monitored continually as atreatment progresses, ensuringthat the systemmaintains a trueisocenter.

Dr. Linder explains,“TrueBeam offers one computer,one screen and a straightforwardconsole so that it delivers precisetreatment in an elegantly simpledelivery system. That reducesthe opportunity for error. And thebeauty of this machine is thatimaging, beam delivery andmotion management are all synchronized,decreasing the amount of scatter radiationand the risk of secondary cancers. Its highquality CT also provides highly accurateimage guidance.”

TrueBeam reduces patient exposure

to X-rays by 25% even as it generates 3-Dimages of the tumor and surroundinganatomy 60% faster than prior radiationtherapy technology.

Dr. Linder is enthused about whatthis means for her patients. “Patients thatswitched to the new machine sawimmediate benefits. With the faster

treatment times, interruption to theirdaily lives is minimized,” she says. “Wealso can play music during treatment tocreate a more soothing environment andclosed-circuit television systems withtwo-way audio keep patients in constantcontact with the radiation therapist.”

“TrueBeam complements ourCyberKnife® stereotactic radiationtherapy and other radiation therapyservices,” Dr. Linder adds. “Having astate-of-the-art, full-service radiationoncology department takes the pressureoff referring physicians to find theappropriate technology for their patientsbecause it’s all in one place.”For more information about the Alvin Lois

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PAPERCAMERAPHOTOGRAPHY

Dr. Rami, co-director of the Minimally Invasive Pituitary and Skull Base Center at GBMC

NewAid the Understanding & Treatment

of Neurological Disorders

ApproachesBY LINDA HARDER

Endonasal Pituitary SurgeryDr. Rami, co-director (with Marc G.Dubin, M.D., FACS) of theMinimally Invasive Pituitary andSkull Base Center at GBMC, isunapologetically enthusiastic aboutthe advantages of endonasal pituitarysurgery to treat micro- and macro-pituitary adenomas. While tumorsin this region of the brain are notcommon, and most are benign, thesymptoms they create can greatlyimpact a patient’s function. Themacro adenomas often cause severedouble vision and other visualimpairments, while the microadenomas secrete excess hormones,leading to prolactinemia and otherendocrine issues.

Until about five years ago, theonly approach to tackle tumors inthe pituitary fossa was a transnasalor sublabial approach, in which theENT made an incision in the noseor gum area followed by a destructiveapproach to the sphenoid sinus. Theendonasal procedure, by contrast,uses an exclusively endoscopicapproach that, surprisingly, providessuperior visualization of the tumor

and surrounding anatomy.“With the endoscope, we can

look at the area as if we were rightin front of the tumor,” exclaimsDr. Rami. “We employ stereotacticnavigation so we know real timewhere we are in relation to the pre-op CT or MRI. We can perform amore delicate dissection and betterpreserve the normal surroundinganatomy. Patients benefit by havinga shorter hospital stay, far less pain,and often a more complete resectionof the tumor than was ever possibleusing traditional techniques.”

The University of Pittsburgh,where Dr. Rami was trained in theuse of the endoscope, pioneered theprocedure, which has since beenextensively reviewed and validatedin the literature over the last fiveyears. “To the best of myknowledge,” he says, “we’re fairlyunique in the Baltimore area foremploying a purely endoscopicapproach, though some surgeons areusing a hybrid approach.

“There is a learning curveassociated with having to look at thevideo screen while moving your

Neurological andneurosurgical specialtiescover a vast range ofdisorders. In this issue,Maryland Physicianexplores advances inthree very diverseareas of this field in itsinterviews with threeMaryland medicalexperts: Amiel W.Bethel, M.D, aboutthe re-emergence oftotal disc replacementin the spine; BimalG. Rami, M.D., aboutendonasal pituitarysurgery; and StewartH. Mostofsky, M.D.,about new understandingof the motor controlissues faced by childrenwith ADHD.


hands; it’s comparable to playing a videogame,“ notes Dr. Rami. “But theinstruments are largely the same, andthe ability to visualize the importantstructures, such as the carotid arteriesand the optic nerves, is extremelyadvantageous.”

Both the endoscopic and thetraditional approach involve collapsingthe capsule of the tumor to remove it.However, in the older technique,physicians would sweep out as much ofthe tissue as possible but depend onpost-operative imaging to determinehow much of the tumor was removed.

Thanks to the surgeon’s ability tovisualize and resect the entire tumorwith the endonasal approach, patientstypically avoid the serial MRIs that arenecessary with partial resections. Theyalso experience fewer symptoms, suchas hyper secretions, and are far lesslikely to need a future craniotomy as aresult of a large tumor that wasn’t fullyresected.

“We’re performing the procedure onlots of patients who originallyunderwent the traditional procedureyears ago but did not have the entiretumor removed,” Dr. Rami concludes.

Total Disc Replacement (TDR)The early research on TDRs began inthe 60s and 70s, but languished formany decades due to researchinvestigation in the United States. Theapproach has regained popularity in thelast 10 to 15 years, chiefly for cervicaldegenerative diseases. Amiel Bethel,M.D., neurosurgeon at the BaltimoreWashington Spine and NeuroscienceCenter, explains, “Unlike fusion, TDRoffers you maintenance of motion at thedisc level, while still relieving pain.When you fuse one disc, it negativelyaffects adjacent discs. TDR is at least asgood as spinal fusion for pain relief andfunction, especially in the cervical area.’

Dr. Bethel comments, “The firstFDA-approved devices emerged threeto four years ago, with three in currentpractice and several more in the wings.

My group has performed many cervicalTDR procedures with excellentoutcomes. In our experience, C2-C3 discreplacements do very well.

“When TDR is used on one level,the return to activity is quicker,” hecontinues. ‘The ideal patient for thisprocedure is younger and has milddegenerative arthritic changes. It givesus another option and prevents discdegeneration in the future. TDR avoidsadjacent disc problems, which affect upto 25% of patients within 10 years.”

Fusion remains the gold standard,especially for patients with more severespondylosis. New inter-body deviceshave a lower profile that decreasesdysphagia and other common sideeffects of this procedure.

“Of course, the majority of patientscan have their degenerative disc diseasetreated without surgical intervention,”Dr. Bethel notes. “Patients should bereferred to doctors who believe in thesealternatives. Care conditioning is veryimportant. I start with treatments such asmedication, exercise, PT, chiropractics,yoga, Pilates, acupuncture, physiatry andpain management. About 30% to 40% ofpatients do well with those treatments. Ifthey fail conservative therapy, we discusstheir options. Of course, some patientshave severe neurologic symptoms thathave progressed to the point where youcan almost tell when they come in thedoor that they’ll need surgery.”

Motor Clues Help Doctors Understand& Predict ADHD SeverityAttention Deficit Hyperactivity Disorder(ADHD), currently the most commonchild behavioral condition, did notbecome an official diagnosis until 1980.Practitioners have since primarily focusedon the behavioral features of the disorder.

In the late 1970s, early studiesidentified excessive overflowmovements and distractible behavior inchildren with excessive hyperactivebehavior. However, little attention waspaid to the motor function effects ofADHD until 2003, when a study


“Total DiscReplacementavoids adjacentdisc problems,which affect upto 25% of patientswithin 10 years.”

–Amiel Bethel, M.D.

“With the endoscope, we can look at the area as if we wereright in front of the tumor…We can perform a more delicatedissection and better preserve the normal surroundinganatomy.”

– Bimal Rami, M.D.

COURTESY

BWMC

observed the presence or absence ofoverflow movements during walkingand other activities, but did notquantify them.

“Despite its prevalence, there is alack of understanding about theneurobiological basis of ADHD,” saysDr. Mostofsky, M.D, director of theLaboratory for Neurocognitive andImaging Research at the KennedyKrieger Institute. “A critical obstacle isthe lack of quantitative measures ofbrain function that would provide a basisfor more accurate diagnosis and effectivetreatment.”

To rectify that situation, Dr.Mostofsky and his colleagues recentlypublished two studies on ADHD thatmeasured the motor control failuresassociated with excessive impulsivity.

“We and other labs are revisitingmotor issues,” says Dr. Mostofsky.“Earlier studies have used bluntmeasurement approaches to overflow.’

In the first study, children withADHD performed a finger-tapping task.Any unintentional, overflow movementsoccurring on the opposite hand werenoted. Researchers developed twomeasurements to quantify the amount ofoverflow – video recording andelectronic goniometers that preciselymeasure the change in angulardisplacement across a joint. Children

with ADHD showed more than twicethe amount of overflow as did typicallydeveloping children, with a high degreeof correspondence between the resultsusing video and goniometermeasurement methods. This was thefirst time that scientists have been ableto quantify the degree to which ADHDis associated with a failure in motorcontrol.

“While we expected to find a strongcorrelation between ADHD andoverflow movements,” notes Dr.Mostofsky, “we were a bit surprised tofind that school age boys exhibited farmore overflow than girls their age. Wethink this is age related, since girlsmature more quickly.”

In the second study, the researchersinvestigated inhibitory control in the

motor cortex using TranscranialMagnetic Stimulation (TMS) to triggermuscle activity in the hand. Researchersmeasured the level of muscle activityand monitored the resulting brainactivity, and also used a paired-pulsestimulation to measure short intervalcortical inhibition (SICI). The degree ofcortical inhibition in children withADHD, measured by SICI, was 40%less than typically developing children.Furthermore, within the ADHD group,less motor inhibition correlated withmore severe behavioral symptom ratings,as reported by parents.

Dr. Mostofsky explains, “Thesefindings provide a window intoidentifying relevant biomarkers ofADHD that can be used to improve howwe diagnose and treat children with thedisorder. Currently, the diagnosis is basedchiefly on behavior reports, which islimiting. Further, from a clinicalstandpoint, it’s helpful to recognize thatchildren with ADHD have difficulty withmotor control, which leads to difficultyperforming handwriting and other finemotor tasks. Study results such as thesemay help guide interventionrecommendations and accommodations inthe school setting. It adds to the growingbody of evidence that these areinvoluntary behaviors, not willful.

“We’ve learned in recent years thatthe long-term outcomes for childrenwith ADHD are not as good as thegeneral population,” Dr. Mostofskyconcludes. “ADHD is associated withhigher rates of incarceration, motorvehicle accidents, and other problematicbehaviors into adulthood. By identifyingphysiologic biomarkers, we can improveour ability to more effectively guidespecific and targeted interventions, andthereby help improve these long-termoutcomes. ”

Stewart H. Mostofsky, M.D.

Bimal G. Rami, M.D., a fellowship-trained neurosurgeon, is co-director of the Minimally

Invasive Pituitary and Skull Base Center at GBMC. Dr. Rami also specializes in spinal cord

stimulation, disc replacement and neuro-oncology.

Amiel W. Bethel, M.D., a fellowship-trained neurosurgeon with the Baltimore Washington

Spine and Neuroscience Center and formerly served as chief of surgery at GBMC. He is also an

Assistant Professor in the Department of Neurosurgery at the University of Maryland School of

Medicine.

Stewart H. Mostofsky, M.D., is a research scientist and director of the Laboratory for

Neurocognitive and Imaging Research at the Kennedy Krieger Institute. He is also an associate

professor of neurology at the Johns Hopkins University School of Medicine.


PAPERCAMERAPHOTOGRAPHY

DIMINISHINGPAIN, RESTORINGFUNCTION


Treat it quickly and effectively for better results


PAINspecialists have come a longway in their understanding of how pain signals aretransmitted and processed, and they have agrowing arsenal of interventions to keep patientsfrom becoming chronically impaired. Newmedications, improvements in existing procedureslike Spinal Cord Stimulation (SCS) andcomplementary medicine (including acupuncture,Reiki and therapeutic massage) join existingmethods of combatting pain.

NEW PHARMACEUTICALS, FORMSAND COMBINATIONSA dizzying array of new pharmaceutical options isproviding greater relief for patients suffering withpain. Newer medications include opiates thatattempt to thwart or diminish misuse. Oxecta, justapproved by the FDA this summer, is the firstimmediate-release Oxycodone HCl medicinedesigned to discourage tampering by making itdifficult to crush or dissolve it.

Pain management physicians also are usingantidepressants, anticonvulsants and seratonin andnorepinephrine reuptake inhibitors (SNRIs) totreat select types of pain. “Cymbalta and Savellahave revolutionized the treatment of fibromyalgiaand, when used off label, other pain conditions,”says Dr. Davies. “Pain and depression typically gohand in hand, and these medications work on bothconditions at the same time.”

BY LINDA HARDERPHOTOGRAPHY BY TRACEY BROWN

Managing patientswith persistent pain can be one of themorefrustrating aspects of primary care.Maryland Physician exploresnew treatments and when to refer to a pain specialist byspeaking with threeMaryland experts: PaulW. Davies, M.D.,board-certified in Pain Management and Anesthesiology; IraD. Kornbluth,M.D., board certified in PainManagement andPhysicalMedicine andRehabilitation; andLaurenP.McNeal,L. Ac., Dipl. Ac., a licensed and board-certified AcupuncturistandHerbalist.

Paul W. Davies, M.D.


Dr. Davies adds, “Lyrica, is anotherrelatively new medication, not dissimilarto Neurontin. It has had a profoundimpact on our management offibromyalgia and many painfulconditions, eliminating or reducing theneed for narcotics.” Lyrica is also FDAapproved for the treatment of diabeticperipheral neuropathy and post herpeticneuralgia. Many doctors use it off labelto treat different forms of neuropathicpain with excellent results.

Newer ways of ingesting or applyingexisting medications, such as Fentanyl,include “lollipops” and submucosal tabs– highly potent forms of this opiateindicated for patients with breakthroughcancer pain.

“We’re also now able to providemore localized treatment for many typesof pain, which helps to minimize sideeffects,” comments Dr. Davies. “A goodexample is Qutenza, which has beenshown effective in treating neuralgiassuch as shingles with a patch that lastsup to three months.”

SYSTEMS MINIMIZE ABUSE,ADDICTIONAbuse and addiction are major societalproblems that often are used inter-changeably, but are very different.Whereas abuse refers to those who usemedications for something other thantheir intended medical purpose,addiction is a chronic, often relapsingbrain disease that causes compulsivedrug seeking and use.

Dr. Davies describes the multi-stepprocess pain specialists use to minimizeabuse and deter addicts. ‘First, we do aninitial urine drug screen to rule out

street or other drugs for which theydon’t have a prescription. We alsoreview the patient’s medical records,checking for evidence of a medicalproblem in an MRI or other procedure.Second, we check pharmacy records todetermine if other doctors haveprescribed narcotics or othermedications with abuse potential. In thelast year, the new electronic pharmacy

database has allowed us to take anincredible leap forward in evaluating apatient’s medication use history. Third,we conduct frequent ongoing drugscreens. When appropriate, we conducta criminal record check. The benefit ofsending patients to a pain managementoffice is that our staff are trained to dothese things.”

Dr. Kornbluth notes, “Painmanagement physicians have a renewedfocus on recognizing and monitoringpatients to prevent abuse. We requirepatients receiving opiates to sign anagreement, then we perform drugtesting to monitor and prevent abuse.If the test is concerning, the patientprobably won’t be allowed into thepractice, and if they become non-compliant, they’re discharged.”

The patient may not be the oneabusing medications. Cancer or elderlypatients may have relatives that selltheir medications on the street. “Theproblem is really society at large,” Dr.Kornbluth adds. “It’s a shame that somereferring physicians still have themisperception that pain physicianscontribute to the addiction problems insociety.”

Dr. Davies concludes, “Doctorshave to consider the health of theircommunity, not just the health of theirpatient, when treating pain.”

ADVANCES IN SPINAL CORDSTIMULATIONBoth physicians believe that spinal cordstimulation is being underutilized byreferring doctors. “When a patient failsto respond to medications and othermore conservative measures, spinal cord

stimulation (SCS) can be very helpful,”says Dr. Davies. “Primary carephysicians should be aware of itspotential to treat peripheralneuropathies and back pain.”

SCS is commonly used for:� Neuropathic pain in upper andlower extremities, i.e., diabeticperipheral neuropathy

� Complex regional pain syndrome(CRPS)

� Back and neck pain

“The battery life of these devices ismuch longer than it used to be and wecan now cover broader areas,” says Dr.Kornbluth. “There are new arrays ofelectrodes that address all of theconditions listed above. Patients canrecharge the SCS at home and use it formany years. An advantage of thisprocedure is that we can conduct a trialprior to implementation of the device.The device can then be implanted inpatients that get good results. Studieshave shown that these proceduresimprove return to work, increase sleepand decrease opioids.”

WHEN TO REFER TO A PAINMANAGEMENT PHYSICIANStudies demonstrate that patients whosepain is managed early do better. “Themedical community now recognizes thatif pain is not treated aggressively earlyon, it has a poorer long-term outcome.Many patients benefit from referral to

“…pain management physicians are veryresponsible. We have a renewed focus onrecognizing and monitoring patients toprevent abuse.” –Ira Kornbluth, M.D.

Ira D. Kornbluth, M.D.


a pain specialist, as we offer morecomprehensive therapies,” Dr. Daviesobserves.

Patients should be referred when:� They require anything morethan a short course of narcoticmedications

� An acute or sub-acute problemcould be remedied withinterventions (i.e., sciatica)

� They have ongoing chronic pain

“If a patient has back pain, forinstance, there’s a lot we can do insteadof just continuing their medications.That often allows them to avoidsurgery,” notes Dr. Kornbluth.

DOES ACUPUNCTURE WORK?Both Dr. Davies and Dr. Kornbluthbelieve strongly that adjunct therapies,such as physical therapy, Reiki,therapeutic massage, and acupuncture,play an important role in painmanagement. This article limitsdiscussion to the role of acupuncture.

After suffering for decades fromWestern skepticism, acupuncture hasbecome a validated approach to treatpain. NIH studies have demonstrated itsvalue for back and knee pain. As aresult, more major insurers are coveringacupuncture for a number of painconditions. “I’m a proponent ofacupuncture, especially when you havea localized myofascial problem orpersistent, intractable pain after aprocedure,” says Dr. Kornbluth.

Lauren McNeal knows first hand thepain relief that can be provided. Shebecame an acupuncturist about 10 yearsago after she found that it was effectivein treating problems she suffered in anauto accident. She states, “It helped myback and neck pain tremendously, so Ibecame a convert.”

WHEN TO REFER FOR ACUPUNCTUREMcNeal believes doctors shouldconsider a referral to acupuncture forvirtually any type of pain. “They maywant to consider acupuncture as a base-line referral before or with physicaltherapy to address any mobility,function or pain issues.”

Acupuncture is more effective whenstarted early, though McNealacknowledges that many patients arereferred only after months of suffering.“We can achieve an excellent success

rate if the pain is treated within threemonths, but we often see people yearsafter the initial pain.”

Ideally, McNeal says, refer foracupuncture prior to injecting a steroidor any numbing agent, as they slow thebody's ability to respond to treatment.

“Acupuncture also can managechronic pain, reducing the ongoing needfor medications,” states McNeal. “Itmay be considered prior to surgery, andcan speed post-op recovery by reducinginflammation and resolving the traumait causes. Combining acupuncture withphysical therapy and/or nutritionalsupplements is an ideal way to treatback pain, increasing patients’ mobilityand function.”

Acupuncture takes time todemonstrate results and the frequencyand duration of treatment vary with thetype of problem. McNeal explains,“Someone with chronic headaches maybe seen once a week for a longer period,while a patient with acute back painmay be seen twice a week for two tothree weeks. The longer the conditionhas been present, the longer it takes toreverse it. But generally, we see asignificant difference in four to sixsessions.”

PROPER CREDENTIALS AREIMPORTANT“It’s important to get a practitioner withgood credentials and a proven track

record,” says Dr. Davies.McNeal concurs. “Most acupuncture

schools provide a masters level ofeducation. The practitioner shouldhave both a state license and boardcertification in acupuncture and havepassed the National AcupunctureBoards. Maryland does not require thatyou pass the national boards to practiceacupuncture, which most patients anddoctors don't realize. The MD statecredential is displayed as “L. Ac.” andthe national credential is displayedas “Dipl. Ac.”

“My advice is to have an open mind,she concludes. Try it before you decideit doesn’t work. Western and alternativemedicine work nicely together.”

Paul W. Davies, M.D., pain

management physician, is the

founder and CEO of Advanced

Pain Management.

Ira D. Kornbluth, M.D., MA,

FAAPMR, CIME, pain management

physician and physiatrist, is

the founder of SMART Pain

Management.

Lauren P. McNeal, L. Ac., Dipl. Ac.,

is a board-certified Acupuncturist,

Herbalist and founder of

Chesapeake Acupuncture & Healing

Arts, LLC..

Lauren P. McNeal, L. Ac., Dipl. Ac.

ShouldyoustoreEHRdataOnsiteorOffsite?

Healthcare IT

BY LINDA HARDER

PHOTOGRAPHY BY TRACEY BROWN

The pros and cons of a client server vs. cloud approach

Lisa Ackerson is business development manager, Sidus BioData

MPLEMENTINGELECTRONICHealth Records (EHRs) forcesphysicians to make myriaddecisions, not the least of whichis whether to store your electronic

patient data onsite or off. While there’snot one right answer for every practice,Maryland Physician spoke with severalMaryland IT experts and a physician thatis managing data onsite, to help youdecide what’s best for your practice. Ourinterviewees were: Theodore C. Houk,M.D., a board-certified Towson internistin solo practice; George Cuthbert, VP,MEDENT® EMR/EHR;Mylon Staton,President/ CEO,DataLink Interactive,Inc.; and Lisa Ackerson, businessdevelopment manager, Sidus BioData.

Client Server ModelChoosing to keep your EHR data onsite,on a server in your practice, is called aClient Server approach. This approachcan be a cost effective solution, especiallyfor smaller practices. Theodore Houk,M.D. is making this approach work forhis practice.

“We use MacPractice CCHIT EHRand were able to quickly ramp up tobegin e-prescribing. Within a month, wefound electronic prescribing to be veryfluid and we’re on schedule to attest toMedicare this fall,” Dr. Houk remarks.

“I learned my first day of medicalschool that I can see things as a threat, achallenge or an opportunity,” muses Dr.Houk. “Electronic data is the future.Providers who don’t adopt it not only willlose Medicare funds, but Carefirst willeventually take a physician's use of EHRinto account when computing reimburse-ment levels in the PCMH (PatientCentered Medical Home) program.”

He continues, “We already hadthe hardware, including a server, twoterminals, two laptops and an iPhone,plus a VPN peripheral drive throughwhich we can call in. We spent less than$5000 on system updates to a version thatwould support EHR, then we spendabout $100/month for e-prescribing and

EHR software, which is far less than whata cloud-based approach would cost us.”

Dr. Houk touts the remote access ofhis client server approach. “I can accessthe data through my iPhone, too, fromvirtually anywhere, and the system alsoworks with an iPad. We started withremote access to visit and allergyinformation; now, we can see our progressnotes and more. The 3G access throughcellular towers means that even in themidst of a hurricane or other weatherissues, I can still capture my claims data.We do keep print-outs of the last year ofprogress notes, including labs, so that wecan access the most critical data in theevent of electronic device failure,” hecontinues. “I back up data to a DVD that Itake off site. If the power goes out, we canrun the server for half an hour with batteryback-up, then finish the day on paper.”

George Cuthbert, VP, MEDENT®

EMR/EHR, which recently expanded toMaryland, concurs with Dr. Houk.“We provide exclusively a client serverapproach, which is less expensive, morereliable and provides faster data retrieval.Servers typically last for eight years andcan cost less than $2000. Practices can

back up onto tape and not have to worryabout their data being hacked into, orlost if a data center goes out of business.During storms such as Hurricane Irene,practices don’t have to worry about losinginternet access or getting slow, unreliableinternet transmission.”

The client server approach is best forphysicians that desire to have hands-onmanagement of their data and are able toaddress security, access, disaster recovery,encryption and storage of backup media,and that can keep up to date withregulatory requirements.

Virtual or Cloud HostingMylon Staton, president/CEO ofDataLink Interactive, Inc., an ITconsulting and management firm based inMaryland, helps physician practices andother businesses deploy and manage theirelectronic data. He is a proponent ofcloud-based hosting of EHRs for mostphysician practices, even ones with asingle location and a few physicians.

“We advise our clients to considervirtualization technologies in lieu of theold school client server model,” he says.“They can leverage virtualization


I

Theodore C. Houk, M.D.


software to take advantage of these newtechnologies and leverage remoteconnectivity from any device such as aniPad. Implementing virtual technologies(Cloud) then makes it easier to move the

system to a data center later on. Thepractice doesn’t have to buy, house andsecurely manage a practice managementserver and terminal server, which requirean air-conditioned environment and takeup space.”

Staton continues, ‘If you have atraditional PC that runs the server andshares data, and that equipment goesdown due to air conditioning failure,weather, or sabotage, you can’t schedulepatients or do your billing. Cloudtechnology is now affordable for smallbusinesses. It introduces redundancy andother safety features to protect access toyour data and to ensure compliance withHIPAA.”

“The cloud is a more efficient way tostore data,” concurs Lisa Ackerson ofSidus BioData, a Maryland owned andoperated Validated CloudHosting/Managed Hosting Servicesprovider since 1999. “You can start bybuying only what you need, and expandin the future as your needs change.”

With Meaningful Use, the number ofhealthcare-oriented data centers is

growing rapidly. Experts advisephysicians to choose a certified datacenter that can provide secure, HIPAA-compliant data storage. IT firms such asDataLink Interactive typically purchase

large amounts of data “racks” at the datacenter and then charge clients for using aportion of those racks.

Staton states, “Single site practiceswith five or fewer physicians may notneed a data center – it’s likely not costeffective. But if you’re looking to upgradeyour technology today, you should moveaway from the client server model and atleast use virtual (Cloud) technology. Asyour practice grows and you need moreIT infrastructure to serve multiple sites,you are then in a position to move to adata center.”

While the cost of cloud hosting is notinsignificant, it can save on capital costsby outsourcing IT infrastructure. Statonestimates that it can cost as little as $500per month for a rented virtual server. Ifyou house your own equipment at a datacenter it can average between $1500 to$2000 per month for data center rack andinternet access.

Ackerson discusses the advantagesof using a data center. “Datacentersprovide an economy-of-scale modelbenefiting small to medium size

practices that may not be able to affordtheir own datacenter with criticalattributes such as backup power, off-sitedisaster recovery capability, securitymonitoring and HIPAA compliance,”says Ackerson. “By using this approach,physicians are freed from the inevitableIT distractions, which results in anincreased focus on patient care.”

Another advantage of using aHIPAA compliant datacenters is thatpractice staff members may not havethe time to stay ahead of the curvewith some of the IT-specific regulationsfound in HIPAA HITECH. In somecases, datacenters have developedmature approaches to compliance byimplementing regulatory requirementssuch as risk analysis/management,security policies and contingencyplanning.

Capturing the data with softwareisn’t the end of the line – physiciansthen have to figure out how to manage itwithout breaching confidentiality. In theevent of server failure, practices thatdon’t have cloud-based data may beunable to access it. If the data is storedon a laptop or other device that is stolen,a thief could hack into the confidentialpatient information.

Practices that participate in an MSOautomatically use a common data center.In Maryland, MSOs need to be EHNAC(Electronic Healthcare NetworkAccreditation Commission) compliantgoing forward.

Considerations for Selectinga Data CenterAsk the following questions whenselecting a center to host your data:� Is the center able to run all typesof software?

� Is the center accredited?EHNAC has introduced a newprogram for accrediting vendorsof health information exchangeservices.

� Is the center truly HIPAAcompliant? Make sure they canprove it, not just claim compliance.

Mylon Staton, President/ CEO, DataLink Interactive, Inc.

Theodore C. Houk, M.D. is a board

certified Towson internist in solo practice.

Mylon Staton is President/CEO of

DataLink Interactive, Inc.

Lisa Ackerson is business development

manager of Sidus BioData.

George Cuthbert is VP of MEDENT®.

“We provide exclusively a client server approach,which is less expensive, more reliable and providesfaster data retrieval.” –George Cuthbert


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OU ARE CURRENTLYtreating a patient with documented chronicpain, a severe anxiety disorder, and ahistory of chemical dependence. Yourworries have now increased exponentially.What is your liability risk? Could you becharged unfairly even if you are treatingthe patient by accepted guidelines? Isyour patient being seen by several otherphysicians without your knowledge? Isthe patient diverting medications you areprescribing? These issues frequentlypresent a dilemma for clinicians, who wantto help stem the public health crisis ofincreased prescription abuse andpotentially lethal overdoses, especially ofopiates and benzodiazepines.

This dilemma is going to change forthe better, for the patient and for thepractitioner. OnMay 10, 2011, GovernorMartin O’Malley signed into law SenateBill 883, legislation to create a PrescriptionDrug Monitoring Program (PDMP) inMaryland, joining 47 other states. For thefirst time, comprehensive information onprescribed and dispensed ControlledDangerous Substances (CDS) on SchedulesII-V will be made available to doctors,pharmacists and other healthcare providers.

What are the goals of the PDMP?PDMPwill provide a powerful clinical toolfor the prevention, early identification,intervention and referral to treatment ofpersons who are addicted to or who abuseprescription drugs. Themost effectivePDMPs have reduced the non-medical use,abuse and diversion of prescription drugswhile preserving legitimate patient access tooptimal pharmaceutical-assisted care. Thisprogramwill also assist bona fideinvestigations by law enforcement, licensingand regulatory agencies to reduce thediversion of CDS to the illegal market.Finally, in partnership with governmentagencies, universities, non-profits,

professional societies and other stakeholders,the PDMPwill provide healthcarepractitioners, policymakers, researchers andthe general public with training andeducational resources about the appropriateclinical use of CDS and prescription drug-related abuse and addiction.

Howwill the PDMP work?When a patient appears in your office, youcan sign into this secure database anddiscover if he or she is being prescribedCDS by other physicians, including howmuch and how often. This data can helpyou to analyze the patient’s use anddetermine if an intervention is needed.Here are the details:

� What data is reported: For each ScheduleII-V CDS prescription, dispensers mustreport data sufficient to identify thepatient for whom the prescription isdispensed, the prescriber, the dispenserand the drug type, dosage and quantity.

� Who must report: Dispensers of CDS,including in-state and non-residentpharmacies. Prescribers are not requiredto report unless they are also dispensing.

� Who is exempt from reporting:1) Licensed hospital pharmaciesdispensing CDS directly to hospitalinpatients, 2) Opioid maintenancetreatment programs, 3) Veterinariandispensers, 4) Pharmacies licensed todispense CDS exclusively to residentsof assisted living, comprehensive careand developmental disabilities facilities,5) Dispensers granted a waiver forinpatient hospice care.

� Who has access to the data: With formalapproval and registration, controlledsubstance prescribers and dispensers willhave electronic access to data close to“real-time.” Health professionallicensing boards and law enforcement,regulatory and investigative agencies will

need either a subpoena or have an existinginvestigation to request PDMP data.Patients and researchers are permittedto request data, with restrictions.

� Where the data is housed and controlled:The Alcohol and Drug AbuseAdministration (ADAA), located in theDepartment of Health andMentalHygiene.

� The technical infrastructure to supportthe PDMP: Now under development toensure reliability, validity, security andconfidentiality.

Howwill this data be legally protected?Prescription data are confidential andprivileged, not subject to discovery,subpoena, or other means of legalcompulsion in civil litigation, and not apublic record.

Unlawful disclosure is a misdemeanorpunishable by up to 1 year imprisonmentand a $10,000 fine.

Who oversees this program?ADAA will work closely with themultidisciplinary Advisory Board onPrescription Drug Monitoring, created bystatute, to advise on program design andimplementation. The Advisory Board willalso evaluate the impact of the PDMP onCDS drug abuse, diversion, and legitimatepatient access.

When will the PDMP be ready?We anticipate that the database will beopen for submitting data and obtainingreports by the summer of 2012.Peter R. Cohen M.D., Medical Director,

Maryland Alcohol and Drug Abuse

Administration. Laura Herrera M.D., MPH,

Chief Medical Officer and Chair of the PDMP

Advisory Board, Maryland Department of

Health and Mental Hygiene.Michael Baier,

PDMP Coordinator, Maryland Alcohol and

Drug Abuse Administration.


Policy

Coming Soon:Maryland’s Prescription DrugMonitoring Program (PDMP)

Peter R. Cohen M.D.; Laura Herrera M.D., MPH;and Michael BaierY

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ITH THE SWEEPINGchanges made by the health care reformlaw, enacted on March 23, 2010, theprovisions in the law which amend thefederal Medicare/Medicaid Anti-Fraudand Abuse Statute (commonly referredto as the Anti-Kickback Statute) have notreceived widespread attention. However,these provisions contained in Section6402(f) of the health reform law, whichlower the criminal intent standard forviolation of the Anti-Kickback Statuteand clarify that a violation of the Anti-Kickback Statute constitutes a false orfraudulent claim, could have far reachingeffects for physicians.

By making it easier for thegovernment to prove a violation of theAnti-Kickback Statute and adding newtools to the government’s arsenal ofweapons used for enforcement purposes,physicians will have significantly greaterexposure to liability. More specifically,Statute 6402(f) lowers the criminal intentstandard under the statute so that thegovernment no longer has to prove thatthe physician had actual knowledge ofthe Anti-Kickback Statute and or aspecific intent to violate the law. Section6402(f) also makes it clear that violationof the statute constitutes a false orfraudulent claim under the False Claims Act.

No one can escape the recentheadlines of how federal agents haverecovered billions of dollars from healthcare fraud judgments. By convertingviolation of the Anti-Kickback Statuteinto a false claim, physicians will now beexposed to liability under the federalFalse Claims Act. Civil penalties imposedfor violation of the False Claims Actinclude treble damages plus a fine from$5,000 to $10,000 per claim. Thesepenalties combined with the administrativesanctions available for violation of theAnti-Kickback Statute can be crippling toany practice.

The Anti-Kickback Statute is not anew phenomenon. It essentially prohibitsthe knowing and willful offer andacceptance of remuneration in cash orin kind to induce the referral of patientsfor the furnishing of items or servicesreimbursed by Medicare or Medicaid.While it is a generally acceptable practicein other industries to reward a person forhis//her business or the referral ofbusiness, such practices are not permittedin the health care industry. The Anti-Kickback Statute makes it a crime to giveand accept rewards for the referral ofbusiness reimbursed by the federal healthcare programs. Upon conviction forviolation of the statute, an individual canbe imprisoned for up to five (5) years, andfined up to $25,000 per violation or both.In addition, physicians who violate thestatute may be subject to civil monetarypenalties up to $50,000 and suspensionor exclusion from participation in federalhealth care programs.

Prior to the amendments made tothe Anti-Kickback Statute, some courtsadopted a criminal intent standardestablished by case law that requires thegovernment to prove that the defendant’shad knowledge of the Anti-KickbackStatute and had a specific intent to violatethe statute. Other courts declined to followthat standard and found that the defendantviolated the Anti-Kickback Statute if onepurpose of the remuneration at issue was toinduce or reward referrals of items orservices reimbursed by Medicare orMedicaid, regardless of the defendant’sknowledge. Passage of the amendments tothe Anti-Kickback Statute now eliminatesthese differences.

The breadth of the Anti-KickbackStatute is staggering. It is commonplacefor physicians in their everyday practiceto be presented with situations that maybe deemed a violation of the statuteincluding, but not limited to, proposed

lease or management servicesarrangements tied to the volume or valueof referrals, the routine waiver ofcoinsurance and deductibles, or the offeror acceptance of free gifts, such as freetickets to sporting events, to inducereferrals. Because of the breadth of thestatute, the Department of Health andHuman Services, Office of InspectorGeneral (OIG) issued safe harborregulations which immunize certainbusiness arrangements from prosecution,as long as all of the criteria of thepertinent safe harbors are met. The OIGhas also issued continuing guidance inother forms, such as Special Fraud Alerts,Advisory Opinions and Bulletins.

Some of the lessons learned fromthese materials are that arrangementsshould be reduced to writing, thecompensation under the arrangementshould not be tied to the volume orvalue of referrals and the compensationarrangement should be equal to the fairmarket value of the space, equipment,services or items being provided.Particularly in this new environment,to the extent possible, a good defenseagainst the possibility of governmentaction will be to structure transactions tocomply with the criteria of all applicablesafe harbors.Laura Katz is a partner in the Baltimore

office of Saul Ewing LLP and is a member of

the firm’s Health Law Practice Group and

Insurance Practice Group. She can be reached

at [email protected].

Compliance

W

The Anti-Kickback Statute:WhatYou Don’t Know Could HurtYou

By Laura L. Katz


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n the 1940’s, a small andinfluential group ofhealthcare leaders beganmeeting to discuss mutualinterests and best practices,as a means of supporting oneanother and ultimatelyimproving the delivery ofhealthcare in Maryland. In1970, that group formalizedto become the MarylandHospital Association (MHA).And today, the organizationserves as a resource andleader for the 66 acute andspecialty care hospitals, aswell as large health systems,across the state. President andChief Executive OfficeCarmela Coyle providedMaryland Physician with someinsights on key priorities ofMHA, including how her staffof 40 are helping Marylandhospitals be the very bestthey can be.

Q:What is the mission andvision of MHA?

A:MHA’s mission is to helpMaryland hospitals and health systemsserve their communities by providingleadership, advocacy, education andinnovative programs and services.Ultimately, we are here to helpMaryland hospitals help people. Ourvision is to be the lead associationshaping health policy, healthcare andhealth in Maryland.

Q: What core services doesMHA provide to hospitals and healthsystems in the state?

A: We have a number of keypriorities, the first of which is to provideadvocacy for Maryland hospitals in bothAnnapolis and Washington D.C. We arealso very involved with financial policy,negotiating for Maryland hospitals asprices are set through the HealthServices Cost Review Commission. Thisis a critically important role, as Marylandis the only state in the U.S. not paidunder federal Medicare rules. We areworking to modernize Maryland’spayment system with the advent offederal healthcare reform. Quality andpatient safety initiatives are significantareas of focus for us, as well as thegeneral services we provide to ourmembers, such as group purchasing andeducational opportunities.

Q: What challenges are mostapparent in the landscape ofhealthcare today?

A:Healthcare has become socomplex in terms of what it actuallytakes to care for a patient. Literally,hundreds if not thousands of peoplemust come together to providespecialized care for each patient. And ofcourse there is a lot of concern aboutrising healthcare costs. More than everbefore, hospitals are being asked to domore with less. Financial constraints intoday’s world of budget deficits isdefinitely the number one challenge.

Q: What are MHA’s goals forthe future?

A:We are working hard to helpMaryland hospitals and health systemsstay at the forefront of innovation. Ourgoal is to help move Maryland hospitalsto the leading edge of quality, safety andpopulation health performance, so thatevery patient receives care of the veryhighest quality. We don’t want to justimprove; we want to LEAD and beknown as the best of the best.

Q: What is the most importantthing for healthcare leaders toknow about MHA?

A: MHA is an organization that isfor, and led by, its members. Second, weare driven not just by what is importantto hospitals, but by the process ofactually shaping health policy,healthcare and the general health of ourcommunity. We are here to serve ourmembers as they straddle the healthcaresystem of today while building thehealthcare system of tomorrow.

Heritage

Maryland Hospital Association:Leadership and Advocacy forState Healthcare Providers

IMHA President and Chief Executive Officer CarmelaCoyle is joined by Richard “Dick” Davidson,Maryland Hospital Association’s first appointedPresident, who served from 1970 – 1991.

By Tracy M. Fitzgerald

N SEPTEMBER 2010, A TEAMof four professionals from Baltimorebased Gilchrist Hospice Care boardeda plane and headed to the Arusha

Region of Tanzania, Africa. There, theyspent two weeks working with theirpartners at the Nkoaranga LutheranHospital, with a goal to better understandhow hospice and palliative care servicesare administered, and ways that theirsupport could help improve quality carefor patients in this under-privileged partof the world.

The need for improved facilitiesand medication systems were obviousimmediately. But the NkoarangaLutheran Hospital was lacking manyof the “basics” too, including resourcesneeded to effectively provide hospice andpalliative care. In some cases, a physicianwas walking eight to ten miles to see andtreat a patient at their home, then turningaround and making the long hike back.Committed to providing financial,technical and educational support to theirpartner in need, among other things,Gilchrist Hospice Care is now fundingthe transportation needs of the Africanhospital, leading to not only moreefficient operations, but also an expansionin the geographical territory served.

“It was reinvigorating to see howmuch they are doing there, with so little,”said Aaron Charles, M.D., AssistantMedical Director for Gilchrist HospiceCare, an affiliate of GBMC Healthcare.“You quickly realize how fortunate weare; we have much more than people inother parts of the world.”

More than 90 hospice organizationsin the U.S., including two others in

Maryland, have established similarpartnerships, through the Foundation forHospices in Sub-Saharan Africa (FHSSA),whose mission is to enhance patient careofferings in Africa through the facilitationof mutually beneficial relationships.While those with limited resources inAfrica benefit from financial support andeducational platforms, participants fromthe U.S. are gaining a deeper under-standing of cultural diversity as well as agreater appreciation for the psychosocialand spiritual aspects of hospice and palliative

care, and of course, some valuable lessonsin how to do more, with less.

“We can’t help but to be better asa result of what we are learning throughthis partnership,” said Cathy Hamel,Executive Director of Gilchrist HospiceCare. “We are helping others and at thesame time, opening new doors forourselves. We are making connectionswith other organizations doing workinternationally, and we are all learningfrom and supporting one another.”

Gilchrist Hospice Care has pledgedto fund $37,000 annually, to keep the coreservices offered by Nkoaranga LutheranHospital intact. As they prepare for theirsecond trip to Tanzania, planned forFebruary 2012, the organization hasimplemented a number of fundraisingprograms to support their commitment,including the making and selling of Africanjewelry at community events, health fairsand conferences. To date, Gilchrist HospiceCare’s volunteer team has made and soldthousands of beaded pieces, with all profitsbenefiting this partnership program.

“This is a big commitment and weare interested in engaging more physicians,

healthcare leaders and members of thecommunity in our efforts,” said Hamel.“The better we are about getting word outabout what we are doing, the more we cando to make a positive difference for thepeople in Tanzania.”

To learn about opportunities forinvolvement with Gilchrist HospiceCare’s partnership with the NkoarangaLutheran Hospital, including volunteer,fundraising and advisory board efforts,please call 443-849-8283.


Good Deeds

By Tracy M. Fitzgerald

Gilchrist Hospice Care Making AWorld of Difference

Maryland Physician would like tohear about your “Good Deeds.”Please share your ideas with usby contacting us via email [email protected].

While in Tanzania, Aaron Charles, M.D.,spent some time observing how hospice andpalliative care is administered to patients,including children, at the NkoarangaLutheran Hospital.

“The better we are about getting word out aboutwhat we are doing, the more we can do to make apositive difference for the people in Tanzania.”

–Cathy Hamel

I

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Documents

Maryland Physician Magazine November/December 2011 Issue