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IN THE MATTER OF * BEFORE THEMAX H. COHEN, M .D. * MARYLAN D BOARD OF

Respondent * PHYSICIANSL ic ense Numbe r: D17567 * Case Num ber: 2001-0549* * * * * * * * * * * *

CONSENT ORDERPROCEDURAL BACKGROUNDOn September 13, 2004, the Maryland Board of Physicians (the "Board")

charged Max H. Cohen, M .D., (the "Respondent"), OOB: 06/08/40, LicenseNumber 017567, with violating the Maryland M edical Practice Act (the "Act"), Md.Health Occ. Code Ann. ("H. G .") 14-101 e t se q. (2000).

The pertinent provisions of the Act under H.O. 14-404(a) provide asfollows:

Subject to the hearing provisions of 14-405 of this subtitle,the Board, on the affirmative vote of the quorum , may reprimandany licensee, place any licensee on probation, or suspend orrevoke a license if the licensee:(22) Fails to meet appropriate standards as determ ined byappropriate peer review for the delivery of qualitym edical and surgical care perform ed in an outpatient

surg ical facility, office , hosp ital, or an y o the r locatio nin this S tate ;(40) Fails to keep adequate medical recordsdeterm ined by appropriate peer review . as

On November 3, 2004, a conference with regard to this matter was heldbefore the Case Resolution Conference ("CRC"). As a result of negotiationsentered into after the CRC, the Respondent agreed to enter into this Consent

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Order, consisting of Procedura l Background, Findings of Fact, Conclusions ofLaw and O rder.

FINDINGS OF FACT

1. At all times relevant hereto, the Respondent, who is board-certifiedin genera l surgery, was and is licensed to practice medicine in theState of Maryland. The Respondent was origina lly licensed topractice medicine in Maryland on December 19, 1974.

2. The Respondent maintains an office for the practice of medicine inBethesda, Maryland and holds hospital privileges at Holy CrossH ospital, S hady G rove Adventist Hospital and S uburban H ospital.

3. On or around December 15, 2000, M id-Atlantic Medical Services,Inc. ("MAMSI") notified the Board that an internal review hadrevealed concerns regarding the Respondent's perform ance of finen ee dle a sp ira tio n ("FNA ") p ro ce du re s.

4. As part of its investigation, the Board referred the matter to thePeer Review Managem ent Committee ("PRMC") of the Medical andChirurgical Faculty of Maryland (liMed-Chi") for a review of theRespondent's practice. The Peer Review Committee ("PRC") wasrequested to focus on all aspects of the care rendered including,but not lim ited to, the number and appropriateness of thep ro cedu re s perfo rmed.

5. The Board provided to the Med-Chi Peer Review Unit a copy of theMAMSI complaint and the Respondent's responses dated January

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5, 2001 and August 30, 2001 and a copy of the R espondent's officerecords for tw elve (12) patients upon w hom the R espondent hadperform ed FN A, as selected by the R espondent.

6. The findings of the peer review ers are set forth below .Patient-Specific Findinqs of FactPatient A

7. Patient A, a fem ale born in 1958, initially presented to theR espondent on June 9, 1998 for a second opinion after havingundergone a hernia repair tw o (2) m onths earlier.

8. O n June 23, 1998, Patient A returned to the R espondent afterundergoing a m am m ogram on June 22, 1998. The radiologicalreport noted a sm all lum p below the right nipple. The screeningm am mogram revealed no m asses, calcifications or other finding. Asonogram w as taken of Patient A 's right breast. The reportindicated no evidence of a cyst and recom m ended surgicalconsultation to consider a biopsy if, on repeat physical exam ination,a clinic ally palp ab le n odu le p ersis ted .

9. O n June 23, 1998, the R espondent noted thickened areas ofPatient A 's right breast and perform ed FN A of tw o (2) areas of herright breast on that date. Both FN A biopsies revealed atypiacharacterized by loosening of cellu lar cohesion, nuclear overlapand m icroapillary form ation. The pathologist suggested tissuebiopsy and histological evaluation to exclude a m ore significant

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10.

11.

12.

13.

14.

p ro life ra tiv e o r n eo pla stic p ro ces s.On July 7, 1998, the Respondent performed FNA of two (2) areasof Patient A's right breast. The pathology report indicated that thespecimen obtained consisted entirely of adipose tissue and wasin ad eq ua te fo r d ia gn ostic c yto lo gic e va lu atio n.On July 21, 1998, the Respondent performed FNA on one (1) areaof Patient A's right breast. The cytopathology report identified"cohesive duct epithelial cells suggestive of papillom a."On July 23, 1998, the Respondent performed a surgical excision ofright breast tissue. The surgical pathology report noted, in te r a lia ,ductal carcinoma in-situ, "extensive, having a cribiform andpapillary pattern. The ductal carcinoma in-situ is present at theinked marg ins."On July 28, 1998 Patient A presented to the Respondent. TheRespondent noted thickened areas in her left breast and conductedFNA of two (2) areas of that breast. The pathology report notedthat the aspirated sam ple was unsatisfactory, containing only bloodand fibroadipose tissue. The Respondent ordered a chest x-ray,CT scan of the thorax, MRI of the right groin/hip area, bone scanand pelv ic u ltra sound.On August 4, 1998, Patient A returned to the Respondent. Theresults of all of the tests the Respondent had ordered werenegative.

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15.

16.

17.

On August 20, 1998, the Respondent performed a re-excision ofright breast tissue. The pathology report indicated that somesections of the excised tissue showed residual intraductalcarcinoma.On September 15, 1998, Patient A's last docum ented visit to theRespondent, the Respondent noted that Patient A had seenconsultants who agreed that she should undergo a m astectom y.The Respondent failed to meet appropriate standards of care forthe delivery of quality medical services to Patient A for reasonsincluding, b ut not lim ited to th e follo wing :a. The Respondent performed five (5) FNAs on Patient A's

right breast, three (3) of which showed a presence ofatypical cells. He also perform ed two (2) FNAs on PatientA 's left breast, the results of which were not diagnostic.There was no indication for the Respondent to perform suchan excessive num ber of FNA biopsies;

b. The Respondent failed to perform an excisional biopsy onPatient A 's right breast once the first FNA of the right breastshowed atypical ce lls; the standard of care required that anexcisio nal biopsy be pe rform ed;

c. The Respondent's documentation was sparse and deficient.He failed to document why he perform ed repeated FNA ofPatient A's right breast rather than an excisional b iopsy;

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Patient B18.

19.

20.

21.

d. On the left side, because of the unsatisfactory sam ple, eitherexcisional biopsy should have been done or the soft natureof the aspirate should have been docum ented;

e. The Respondent failed to document adequately why heperformed FNA of Patient A's left breast nor did hedocument that he followed Patient A appropriately afterperform ing FNA and obtaining an unsatisfactory sample.

Patient B, a female born in 1978, initially presented to theRespondent on Novem ber 19, 1996, after finding that her left breastfelt "m ore lum py" than usual during her m onthly self-exam ination.The Respondent examined Patient B's breasts and noted a slightthickening of the lower and medial aspects of the left breast ands eve ra l s kin le sio ns .On March 20, 2001, Patient B returned to the Respondent afternoticing a thickened area on her left arm . The Respondent notedthat the area was nontender w ithout adenopathy. The Respondentperformed two (2) FNAs of areas on Patient B's left arm .The pathology diagnosis of the March 20, 2001 FNA showed a

spindle mesenchymal cell lesion, w ith the differential diagnosisincluding spindle cell tum or. Although definite m alignant featureswere not present, malignant spindle cell tumor could not be

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22.

23.

24.

25.

26.

excluded. The pathology report also noted that prom inentinflam m atory infiltrates were present in the sam ple. Tissue studyw as recom mended for further evaluation.O n April 19, 2001, P atient A returned to the R espondent. TheRespondent noted that the area on her left arm was less prom inent.The Respondent conducted FN A of two (2) areas of Patient B 's leftarm.The initial pathology report of the April 19, 2001 FNA s indicated adifferential diagnosis of reactive/reparative processes (includingnodular fasciitis) and spindle cell neoplasm . Tissue study wasre co mm en ded fo r fu rth er e va lu atio n.O n M ay 3, 2001, the pathologist issued an am ended report of thefindings of the A pril 19, 2001 FN As after discussing the case w iththe Respondent and correlating the results with the decreasing sizeof the m ass. The am ended pathology report concluded that a"re ac tiv e/re pa ra tive p ro ce ss is fa vo re d."O n M ay 3, 2001, the Respondent noted that he discussed withPatient B "each of the diagnoses (potentials) m entioned w ithtreatm ent for each in light of regression." The Respondent alsonoted that he discussed the "reparative process" with P atient B .O n M ay 9, 2001, the last recorded entry in Patient B's chart, theR espondent docum ented that he telephoned Patient Banddiscussed the M ay 3 am endm ent of the pathology report "favoring

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27.

Patient C28.

29.

reactive/reparative process."The Respondent failed to meet the appropriate standards of carefor the delivery of quality medical services to Patient B for reasonsincluding, but not lim ited to, the follow ing:a. The Respondent failed to adequately document his

treatm ent rationale or follow-up for Patient B;b. The Respondent failed to measure the lesion and document

the measurement of the lesion on Patient B's arm; andc. The Respondent failed to perform either a core biopsy or an

excisional biopsy after the first FNA revealed a possibles pin dle ce ll n eo pla sm .

Patient C, a female born in 1961, initially presented to theRespondent on October 14, 1999, after a bilateral mammogramperformed on October 4, 1999 showed a suspicious abnormality ofthe left breast corresponding to a palpable nodule. Four (4)clusters of calcifications were also found in the left breast.U ltrasound guided core biopsy of the solid nodule wasrecommended, as was an stereotactic core biopsy of thecalcifications, if the calcifications were new or increasing whencompared to prior m ammogram s.On October 14, 1999, the Respondent performed a FNA of two (2)areas of Patient C 's left breast. The cytopathology report indicated

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30.

31 .

32.

33 .

34 .

that the sample was unsatisfactory, consisting primarily of bloodand rare poorly preserved ductal cells.On November 23, 1999, the Respondent performed a second FNAof two (2) areas of Patient C 's left breast. The results were againunsatisfactory, consisting of fibroadipose tissue and blood.On December 9, 1999, the Respondent performed a core biopsy ofthe left breast nodule that revealed intraductal carcinom a, grade 2.Thereafter, the core biopsy slides were sent to the Armed ForcesInstitute of Pathology ("AFIP") for review. AFIP 's conclusion wasductal intra-epithelial neoplasia, grade 3 (DIN 3).On December 20, 1999, the Respondent performed a left partialmastectomy with excision of nodules and tissue of Patient C 's leftbreast. The pathology report for this procedure indicated"extensive intraductal carcinoma high-grade w ith cancerization oflobules, focal area of extension into the fibroadenomatoid nodulew ith positive superior and very close to posterior and medialmargin."The Respondent failed to meet the appropriate standards of carefor the delivery of quality medical services to Patient C for reasonsincluding, but not lim ited to, the follow ing:a. The Respondent's documentation is scanty; andb. The Respondent failed to perform a core biopsy of the

palpable mass and stereotactic biopsy of the calcification-9 -

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Patient D35.

36 .

37 .

38 .

39.

based on the abnormal mammogram findings. The two (2)unsatisfactory FNAs were unnecessary; FNA was not theappropriate diagnostic technique in this situation.

Patient 0, a female born in 1947, initially presented to theRespondent on February 4, 1986 after finding a lump in her leftbreast. Patient 0 continued to see the Respondent for routinefo llo w-u p fo r se ve ra l y ea rs th ere afte r.On December 19, 1997, Patient 0 underwent a screeningmammogram, the results of which were stable, with no masses,significant calcifications or other findings. The radiological reportnotes that Patient D 's breast tissue is extremely dense and that shehad had a cyst aspiration (date unspecified) that had dem onstratedsom e atypical cells.On January 20, 1998, the Respondent noted an area of thickeningon Patient D 's lower left breast and performed an FNA of that area.The cytologic diagnosis was atypical ductal proliferative lesion; abiopsy w as recom mended for a definitive diagnosis.On February 3, 1998, the Respondent noted prom inences onPatient D's right breast and performed a FNA of that breast. Theresults suggested ductal epithelial hyperplasia without atypia andfib ro ad en om a w as fa vo re d.On February 13, 1998, the Respondent performed an excisional

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40.

41.

42.

43.

44 .

45.

46 .

biopsy of tissue from Patient D 's left breast. The surgical pathologyre po rt in dic ate d fibro cys tic ch an ges .On June 17, 1999, Patient 0 underwent a screening mammogramthe results of which were stable with no mammographic evidence ofmalignancy.On February 1, 2000, the Respondent examined Patient 0 andnoted increased thickening in areas of her right breast. TheRespondent performed FNAs of the right lower and lower centralbreast, the results of which were inconclusive. A biopsy wasrecommended.In the Respondent's February 15, 2000 office note, he docum entedthat he discussed the prior inconclusive FNAs with Patient 0, whomhe noted "prefers repeat."On February 15, 2000, the Respondent performed FNAs of PatientD's right m id-interior breast. The sample was insufficient forcytologic evaluation as blood elements were present and no breastepithelial cells w ere seen.On March 2, 2000, the Respondent repeated the FNA of PatientD's right breast. The results were once again inconclusive.On March 13, 2000, the Respondent conducted a surgical excisionof Patient D's right breast tissue. The pathology report indicatedfibrocystic changes w ith strom al fibrosis and adenosis.The Respondent failed to meet the standard of care for the delivery

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Patient E

47.

48.

of quality medical services to Patient D for reasons including, butn ot lim ite d to , th e fo llowin g:a. The Respondent performed eight (8) right FNAs from

January 1998 through March 2000, and right excisionalbiopsies on four (4) occasions. The number of FNAs isexcessive, especially since most were inconclusive. Thestandard of care requires excisional biopsy to be perform edwhen the non-diagnostic cytology was seen yet concernregarding the area rem ained; and

b. The Respondent noted that Patient D "preferred" repeatFNAs. The surgeon has the responsibility to explain why thiswas not an adequate approach.

Patient E, a female born in 1946, had initially presented to theRespondent in 1983 for removal of a mole. She returned to theRespondent in 1995 for "follow-up," presumably of a December1994 mammographic finding of right breast cysts. Patient E'sfam ily history was positive for breast cancer on her m aternal side.On February 11, 1998, Patient E underwent a mammogram andafter a finding of a right breast nodule, she also underwentultrasound of the right breast. The radiological report indicated thatthe nodule "most likely represents a benign lesion such as afibroadenom a," but recommended that the nodule be m onitored.

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49.

50 .

51 .

52 .

On February 11, 1999, the Respondent performed a right breastFNA, the results of which were unsatisfactory as the samplecontained fibroadipose tissue and rare ductal cells. TheRespondent FNA without sonographic orerformed themammograph ic guid ance .From May 1999 through July 1999, the Respondent conductedeight (8) left breast FNAs for a diagnosis of mammographicabnormalities. A ll of the cytopathology reports for the FNAsindicated unsatisfactory sam ples, consisting of only fibroadiposetissue and blood. The Respondent performed all eight (8) of theFN A's w ithout sonographic or m ammographic guidance.From December 1999 to January 2000, the Respondent performedfour (4) right and two (2) left FNAs. In two (2) of the samples,d uc ta l c ells w ere n ot id en tifie d.The Respondent failed to meet the standard of care for the deliveryof quality medical services to Patient E for reasons including, butnot lim ited to the follow ing:a. The Respondent performed an excessive number of FNAs

o n th is p atie nt;b. Respondent'she of FNAs In response tose

mammographic abnormalities, as opposed to a palpablelum p, is inappropriate. The standard of care requires either acore biopsy or needle localization and biopsy with ultrasound

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P atient F53.

54.

55.

56.

57.

o r s te reota ctic guid ance ;c. The Respondent failed to perform excisional biopsy in those

instances w here atypical cytology was reported; andd. The Respondent failed to perform a surgical biopsy after a

FNA showed no ductal cells.

Patient F, a female born in 1942, initially presented to theRespondent in 1994 for excision of m elanom a of her m id-back.On March 30, 2000, the Respondent noted that Patient F'smammogram revealed an abnormality of the upper right breast (themammogram report was not included in the record) and performedan FNA of that area. The resulting pathology report indicated thatthe sam ple was negative for m alignant cell.The Respondent repeated the right breast FNA on April 10, 2000.The pathology report indicated that the sample was negative andcontained fibroadipose tissue only.On April 12, 2000, Patient F underwent a bilateral low-dosemammography. The radiological report stated that a new andprobably benign nodule was located in the anterior right breast, acollection of calcifications was found in the left breast and scatteredcalc ific atio ns were p re sent b ila te ra lly .On April 13, 2000, the Respondent performed an FNA on PatientF's left breast. The pathology report stated that the sample was

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58 .

Patient G59 .

60.

61.

62.

unsatisfactory as it contained fatty tissue.The Respondent failed to meet the standard of care for the deliveryof quality medical services to Patient F for reasons including, butnot lim ited to, his failure to localize m ammographic abnorm alities byeither ultrasound or m ammographic guidance before perform ing theFNA.

Patient G , a female born in 1955, initially presented to theRespondent in December 1999, after a mammogram taken earlierthat month revealed a new right breast nodule containing multiplecalcifications suspicious for neoplasm and a faint group ofcalcifications in the left breast that had not appeared on previousstudies.The Respondent performed FNAs of Patient G 's right breast onDecember 16, 1999, December 23, 1999, December 28, 1999 andJanuary 31, 2000. He also performed an FNA of Patient G 's leftbreast on January 18, 2000.W ith the exception of the January 31, 2000 FNA, the study resultswere unsatisfactory or non-diagnostic. The January 31, 2000 FNAstudy w as suggestive of ductal hyperplasia.On January 7, 2000, the Respondent performed an excision of aright lower breast lesion during which he excised a lentiginousju nc tio na l n evus .

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63. On March 10, 2000, the Respondent performed a lumpectomy ofPatient G 's right breast, the results of which revealed proliferativefibrocystic disease, negative for in-situ or invasive carcinom a.

64. The Respondent failed to meet the standard of care for the deliveryof quality medical services to Patient G for reasons including, butn ot lim ite d to , th e fo llowin g:a. The Respondent performed an excessive number of FNAs

on Patient G as he repeated FNAs several times the resultsof which showed no ductal cells, rather than perform ingexcisional biopsy; and

b. The Respondent's use of FNA to biopsy areas ofcalcifications is a breach of the standard of care. Thestandard of care requires stereotactic core biopsy or needlelocalization and excision of those areas.

CONCLUSION OF LAWBased on the foregoing Findings of Fact, the Board concludes as a matter

of law that the Respondent's actions constitute a violation of the appropriatestandard of care for the delivery of quality medical services, in violation of H.O . 14-404(a)(22) and failure to maintain adequate medical records, in violation ofH .O . 14-404 (a )(4 0).

ORDERBased on foregoing Findings of Fact and Conclusions of Law, it is this

j 5'4l day of I eCt'li..{,bt~ 2004, by a majority of the quorum of the(-16-

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B oard considering this case:ORDERED that the R espondent's license to practice m edicine be placed

on Probation for a m inim um of one (1) year) and un til h e s ucc ess fu lly co mple te sthe follow ing term s and conditions:

a. The R espondent shall, w ithin six (6) m onths of the date of thisC onsent O rder, successfully com plete a Board-approved course in each of thefo llo win g a re as :

1. m edical record-keeping; and2. diagnosis of breast lesions.

b. The R espondent's practice shall be subject to a peer review by anappropriate peer review entity. This peer review shall be conducted and shallinclude review of records of patients treated after the R espondent's successfulcom pletion of the tw o (2) Board-approved courses set forth above; and it isfurther

ORDERED that any violation of the term s and/or conditions of this O rdershall be deem ed a violation of probation and/or this C onsent O rder; and it isfurther

ORDERED that the R espondent shall com ply w ith the M aryland M edicalPractice Act and all law s, statutes and regulations pertaining to the practice ofm edicine; and it is further

ORDERED that if the R espondent violates any of the term s and conditionsof this probation and/or this C onsent O rder, the Board, in its discretion, afternotice and an opportunity for an evidentiary hearing before an Adm inistrative Law

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Judge at the Office of Adm inistrative Hearings if there is a genuine dispute as tothe underlying material facts, or an opportunity for a show cause hearing beforethe Board, may impose any sanction which the Board may have imposed in thiscase under 14-404(a) and 14-405.1 of the Medical Practice Act, including areprimand, probation, suspension, revocation and/or a monetary fine, saidviolation being proved by a preponderance of the evidence; and it is further

ORDERED that the Respondent shall not petition the Board for earlyterm ination of the term s and conditions of this Consent Order; and it is further

ORDERED that the Respondent is responsible for all costs incurred infulfilling the term s and conditions of this Consent O rder; and it is further

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ORDERED that this Consent Order shall be a PUBLIC DOCUMENTpursuant to Md. State Gov't Code Ann. 10-611 et s eq . (1999).

IZ~.I(D~

Oaf-< ~ '2sI < ,j--e !.,' ~ / . /t.U. . ." \~V~ ( -Harry C. Knipp, M .D., hair

M arylan d B oa rd of P hysician s

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CONSENTI, M ax H . C ohen, M .D ., acknow ledge that I am represented by counsel

and have consulted w ith counsel before entering this C onsent O rder. By thisC onsent, I adm it to these allegations, and I agree and accept to be bound by theforegoing C onsent O rder and its conditions.

I acknow ledge the validity of this C onsent O rder as if entered into after theconclusion of a form al evidentiary hearing in w hich I w ould have had the right tocounsel, to confront w itnesses, to give testim ony, to call w itnesses on m y ow nbehalf, and to all other substantive and procedural protections provided by thelaw . I acknow ledge the legal authority and jurisdiction of the Board to initiatethese proceedings and to issue and enforce this C onsent O rder. I affirm that Iam w aiving m y right to appeal any adverse ruling of the Board that I m ight havefollow ed after any such hearing.

I sign this C onsent O rder after having an opportunity to consult w ith

counsel, voluntarily and w ithout reservation, and I fully understand andcom prehend the language, m eaning and term s of the C onsent O rder.

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STATE OF MARYLA,ND ..