Health and Human Services: George%20Kalousek%20MD%207%2023%202003

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INTEGRITYGREEMENT

BETWEEN THE

OFFICE F INSPECTORGENERAL

OF THE

DEPARTMENTF HEALTH ND HUMAN ERVICES

AND

G E O R G E ALOUSEK, M.D.

George Kalousek, M.D. ("Kalousek") hereb y enters into this Integrity Agre em ent

("Agreement") with the Office of Inspector General ("OIG") of the United S tates

Department of Health and Hum an Services ("HHS") to promote com pliance with the

statutes, regulations, program requirements, and written directives of Medicare.

Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. 5 1320a-

7b(f)) ("Federal health care program requirements") by Kalousek. This comm itment topromote com pliance applies to any entity that Kalousek ow ns or in which Kalousek has a

control interest, as defined in 42 U.S.C . 1320a-3(a)(3), and Kalousek's and any such

entity's Covered Persons as defined in Section I1.C. Contem poraneously with this

Agreement. K alousek is entering into a S ettiement Agreem ent with the United States. and

this Agreem ent is incorporated by reference into the SettIement Agreemen t.

A . The period o f compliance obIigations assumed by K alousek under this

Agreem ent shall be five years from the effective date of this Agreem ent ("Effective



a. Ka lousek and any co-ow ners, officers, directors, and employees;

b. all contractors and agents that provide patient care items orservices or that perform billing or coding functions on behalf o f

Kalousek; and

c . all other individuals responsible for the provision, m arketing , or

docume ntation of items or services reimbursable by Fed eral health

care program s, or in the preparation of claims, repor ts, or other

requests for reimbursemen t for such items or services.

Kalousek shall establish a Com pliance Program that, at minimum , includes the

following elements:

A. Com pliance Contact

Within 30 days after the Effective Date, Kalousek shall designate a person to be

responsible for com pliance activities ("Comp liance Contact"). Th e Com pliance Conta ct

shall (1) develop and im plement policies, procedures, and practices designed to e nsure

compliance with the ob ligations herein and with Federal health c are program

requirements; and (2) shall respond to questions and concerns from Co vered Person s and

the OIG regarding compliance with the Agreem ent obligations. The name a nd phone

number o f the Com pliance Co ntact shall be included in the Implementation Report. Inthe event a new C ompliance Contact is appointed during the term of this Agree men t,

Kalousek shall notify the OIG , in writing, within 15 days after such a cha nge.



C. Written Policies and Procedures

W ithin 90 da ys after the Effective Date, Kalousek shall develop, implement, andmake available to all Covered Pe rsons written policies that address the following:

1 . Kalou sek's comm itment to operate his business in full compliance with

all Federal health care program requirements;

2. Kalousek 's requirement that all Covered Persons shall be expected to

com ply with all Federal health care program requirements and w ith

Kalou sek's own Policies and Procedures, as implemented pursuant to

Section I1I.C (including the requirements of this Agreem ent);

3 . The requirement that all of Kalousek's Covered Persons shall be

expected to report to Kalousek or the Compliance C ontact suspected

violations o f any Federal health care program requiremen ts or Kalou sek's

own Policies and Procedures. Any Co vered Person who m akes an inquiry

regarding com pliance with Federal health care program requirements shallbe able to do so witho ut risk of retaliation or other ad verse effect;

4. The com mitment o f Kalousek to remain current with all Federal health

care program requ irements by obtaining and reviewing progra m

mem oranda, new sletters, and any other correspondence from the carrier

related to Federal he alth care program requirements;

5. Th e proper procedures for the accurate preparation and subm ission of

claims in accordance with Federal health care program requirem ents; and



of an y revisions, the relevant portions of an y such revised Policies and Procedures shall

be m ade available to all individuals wh ose job fbnctions are related to those Po licies and

Procedures.

Co pies of the written policies and procedures shall be included in the

Implem entation Report. Copies of any written policies and procedures that are

subsequen tly revised sh all be included in the Annual Rep ort.

D. Training and Certification

Within 90 days after the Effective D ate and at least once each y ear thereafter,

Kalousek and Covered Persons involved in the delivery of patient care items or serv ices

and/or in the preparation or submission of claims for reimbursem ent from any Federal

health care program shall receive at least 4 hours of training from an individual or entity,

other than Kalousek or another Covered Person. The training shall be conducted by

individuals with expertise in the relevant subject areas, preparation or subm ission of

claims to Federal health care programs for the types of services provided by Kalo usek

and may be received from a variety of sources (i.e.,CME classes, hospitals, associations,carriers).

New Cove red Persons involved in the delivery of patient care items or services

andlor in the preparation or submission of claims for reimbursem ent from any Fed eral

health care program shall receive the training described ab ove within 30 days after

becom ing a Cov ered Person or within 90 days after the Effectiv e Date, whichev er is later.

Th e training for New Covered Persons may either be provided internally by Co veredPersons wh o have completed the required ann ual training or externally by a qualified

individual or entity. Until they have received the requisite training, such New C ove red

Persons shall work under the direct supervision of a Covered Person w ho has receiv ed



3. Th e legal sanctions for im proper billing or other violations of the

Federal health care program requirements; and

4. Exam ples of proper and improper billing practices.

Each Covered Person shall annually certify in writing that he or she has received

the required training. Th e certification shall specify the type of training received and the

date the training was received. Kalousek shall retain the certifications, along with the

training cou rse materials. Th e training course materials shall be provided in the Annual

Report.

E . Third Party Billing

Kalousek presently contracts with a third party billing com pany to su bmit claims

to the Federal health care program s. Kalousek represents that he d oes not have an

ownership or control interest (as defined in 42 U.S.C. 5 1320a-3 (a)(3)) in the third party

billing co mpa ny and is not em ployed by, and does not act as a consultant to, the thirdparty billing company . If Kalou sek intends to obtain an ow ners hip or control interest (as

defined in 42 U.S.C. 5 l32Oa-3(a)(3)) in, or become em ployed by, or becom e a

consultant to, any third party billing company during the term of this Agreem ent,

Kalousek shall notify the O IG 30 days prior to any such proposed involvem ent.

Within 90 days after the Effective Date, Kalousek shall obtain and include in the

Implem entation Rep ort a certification from the third party billing com pany that it (i) ispresently in com pliance with all Federal health care program requirements as they relate

to submission of claims to the Federal health care programs; (ii) has a policy of not

knowingly em ploying any person wh o has been excluded, debarred, or otherwise



F. Review Procedures.

I . Genera l Description.

a. Retention of Independent Review Organization. Within 90 days

after the Effective D ate, Kalousek shall retain an ind ividual or entity,

such as a nurse reviewer or an accounting, auditing, or consulting

firm (hereinafter "Indep enden t Review Organ ization" or "IRO"), to

perform reviews to assist Kalousek in assessing and evaluating its

billing and coding practices pursuant to this Agreem ent. Each IROretained by Kalousek shall have expertise in the billing, cod ing,

reporting, and other requirements of the particular section of the

health care industry pertaining to this A greeme nt and in the general

requirements of the Federal health care program(s) from which

Kalousek seeks reimbursement. Each IRO shall assess, along with

Kalousek, whether it can perform the IRO review in a professionally

independent fashion taking into account any other businessrelationships or other engagements that may exist. Th e IRO (s)

review shall address and analyze Kalou sek's billing and coding to

the Federal health care programs ("Claims Review").

b. Frequency of Claims Review. The Claims Review shall beperformed annually and shall cover each of the Rep orting Period.

The IRO (s) shall perform all components of each an nual C laimsReview.

c. Retention of Records. The IRO and K alousek shall retain and



suppo rting documentation available at Kalousek's office or under

Kalou sek's control and applicable billing and coding regulations and

guidan ce to determine whether the claim submitted was correctly

coded, subm itted, and reimbursed.

i. If the Error Rate (as defined in Appendix A) for the

Discovery Sample is less than 5%, no additional sampling is

required, nor is the Systems Review required. (Note: Th e

threshold listed abov e does not imply that this is an

acceptable error rate. Acco rdingly, Kalou sek should , as

approp riate, further analyze any errors identified in theDiscovery Sample. Kalousek recognizes that the OIG or other

HH S com ponent, in its discretion and a s authorized by

statute, regulation, or other appropriate authority may also

analyze or review Paid Claims included or errors identified in

the Discovery Sam ple.)

ii. If the Discovery Sam ple indicates that the Error Ra te is5% or greater, the IRO shall perform a Full Sam ple and a

Systems Review, as described below.

b. Full Samp le. If necessary, as determin ed by procedures se t forth

in Section III .F .2 4 the IRO shall perform an additional samp le of

Paid Claims using commonly accepted sam pling methods and in

accordance with Appendix A . The Full Sam ple shall be designed to:(1 ) estimate the actual Overpayment in the population with a 90%

confidence level and with a maximum relative precision of 25% of

the point estimate and (2 ) conform with the Centers for Medicare



approp riate Federal health care program payo r, including the

Me dicare contractor(sarrier, fiscal intermediary, or DMERC),

for appropriate follow-up by that payor.

c. System s Rev iew. If Kalou sek's Discovery Samp le identifies an

Error Rate of 5% or greater, Kalousek's IRO shall also conduct a

System s Rev iew. Specifically, for each claim in the Discovery

Sam ple and Full Sample that resulted in an Overpaym ent, the IRO

shall perform a "walk through" of the system(s) and process(es), that

generated the claim to identify any problems or weak nesses that may

have resulted in the identified O verpayments. Th e IRO shall provideto Kalousek observations and recommend ations on suggested

improvements to the system(s) and the process(es) that generated the

claim.

d. Rep aym ent of Identified Overpaym ents. In accordance with

Section 1II.G. 1, Kalousek shall repay within 30 days any

Overpaym ent(s) identified in the Discovery S amp le or the FullSam ple (if applicable), regardless of the Error Rate, to the

appropriate payor and in accordance with payor refimd policies.

Kalousek shall make available to the OIG any and all documentation

that reflects the re h n d of the Overpayment(s) to the payor and the

associated d ocumentation.

3 . Claims Review Report. Th e IRO shall prepare a report based upon theClaim s Review performed (the "Claims Review Report"). Information to be included in

the Claims Review R eport is described in Appendix A.



necessary . T o resolve any concerns raised by the OIG, Kalou sek may request a meeting

with the O IG to discuss the results of any Claims Review submissions or findings;

present any additional or relevant information to clarify the results of the Claim s Review

to correct the inaccuracy o f the Claim s Review; an d/or propose a lternatives to the

proposed Validation Review . Kalou sek agrees to provide any additional information as

may be requ ested by the OIG under this Section in an expedited manner. The OIG will

attempt in good faith to resolve any Claims R eview with K alousek prior to conducting aValidation Review . How ever, the final determination as to whe ther or not to proceed

with a Validation Review shall be made at the sole discretion of the OIG .

7. Independence Certification. The IRO shall include in its report(s) toKalou sek a certification or sworn affidavit that it has evaluated its professional

independ ence with regard to the Claim s Review and that it has concluded that it was, infact, independent.

G . Ineligible Persons

1. De3nition. For purposes o f this IA , an "Ineligible Person" shall be anindividual or entity who : (a) is currently excluded, debarred, suspended, or otherwise

ineligible to participate in the Federal health care program s or in Federal procurem ent or

nonprocurement program s; or (b) has been convicted of a criminal offense that falls

within the ambit of 42 U.S.C. $ 1320a-7(a), but has not yet been excluded, de barred,suspended, or o therwise declared ineligible.

2. Screening Requirements. Kalousek sh all ensure that all owners,officers, directors, employ ees, contractors, and agents of Ka lousek are not Ineligible

Persons. To ensu re that such persons are not Ineligible Persons, KaIousek shall screen

such persons prior to engaging their skrvices by: (a) requiring suc h persons to disclose



immediately any debarment, exclusion, suspension, or other event that makes such person

an Ineligible Person.

If Kalousek ha s actual notice that such person has becom e an Ineligible Person,

Kalousek shall remov e such person from responsibility for, or involveme nt with,

Kalousek's business operations related to the Federal health care programs and shall

remove su ch person from any position for wh ich the person's comp ensation or the items

or services rendered, ordered, or prescribed by the person are paid in wh ole or part,

directly or indirectly, by Federal health ca re program s or otherwise with F ederal funds at

least until such time as the person is reinstated into participation in the Fed eral health

care programs.

4 . Pending Charges and Proposed E xclusions. If Kalousek has actual

notice that a person identified in Section III.G.2 is charged with a criminal offense related

to any Federal health care program, or is proposed for exclusion d uring his or herv

employm ent, involvement, or contract term, Kalousek shall take all appropriate actions to

ensure that the responsibilities of that person have not and sh all not adversely affect the

quality of care rendered to any ben eficiary, patient, or resident, or the ac curacy o f anyclaims submitted to any Federal health care program.

H. Reportinp: of Ov erpay men ts and Material D eficiencies

1 . Overpayments

a. Definition of Overpaym ents. For purposes of this Agreement, an"Overpayment" shall mean the amount of money Kalousek has

received in excess of the am ount due and payable under any Federal

health care program requirements.



to quantify the Overpaym ent amou nt along with a schedu le of when

such work is expected to be com pleted. Notification and repayment

to the payor shall be don e in accordance with the payo r's policies,

and for Medicare contractors, shall include the information

contained on the Overpaym ent Refund Form , provided as Appendix

B to this Agreeme nt. Notwithstanding the above, notification and

repayment of any Ov erpayment am ount that routinely is reconciledor adjusted pursuant to policies and proced ures established by the

payo r shall be handled in accordance with such policies and

procedures.

2. Material Deficiencies.

a. Definition of Material Deficiency. For purposes of this

Agreement, a "Material Deficiency" means anything that involves:

(i) a substantial Ov erpayment; or

(ii) a matter that a reasonable person would consider a

probab le violation of criminal, civil, or adm inistrative law s

applicable to any Federal health care program for which

penalties or exclusion may be authorized.

A Material Deficiency may be the result of an isolated event or a

series of occurrences.

b. Reporting of Material Deficiencies. If Kalousek determines, by



Federal health care programs, Ka lousek shall notify that party of this Agreem ent. This

notification will include a copy o f the Agreem ent, the remaining reporting period of the

Agreement, and a sum mary o f Kalou sek's obligations under the Agreement. In addition,

Kalou sek sha ll notify the OIG of such relationship as described in Se ction XI.4.

A. Implementation Report

Within 120 days after the Effective Date, Ka lousek shall sub mit a written report to

OIG summ arizing the status of its implementation of the requirements of this Agreem ent.This Im plementation Report shall include:

1. The name, address, and phone number of Kalousek's Compliance C ontact;

2. A c o p y b f the notice Kalousek posted in his office as described in Section

1II.B and a description of where and when the no tice was po sted;

3. A copy of the written policies and procedures required by Section 1II.C;

4. A certification signed by Kalousek attesting that the Policies and

Procedures are being implemented and have been made available to all

Covered Persons;

5 . Acopy of all training materials used for the training required by SectionIII.D, a description o f the training, including a sum ma ry of the topics

covered, the length of the session(s), and a schedule o f wh en the tra ining

session(s) were held;



reimbursement consulting, and the proposed start and completion dates of

the first annual claims review;

9. A certification from the IRO regarding its professional independence with

respect to Kalou sek;

10. A list of all Kalousek's locations (including locations and mailing

addresses), the corresponding nam e under which each location is doing

business, the corresponding phone numbers and fax numbers, each

location's Medicare provider identification number(s), and the nam e and

address of the M edicare contractor to which K alousek currently subm itsclaims; and

11 . A certification from K alousek stating that he has reviewed the

Implementation Report, he has made a reasonable inquiry regarding its

content and belikves that, upon such inquiry, the information is accurate

and truthful.

B. Annual Reports

Kalousek shall subm it to the OIG A nnual Reports with respect to the status of and

findings regarding Kalousek's compliance activities for each of the five Reporting

Periods. Th e first Annual Report shall be received by the OIG no later than 60 days after

the end of the first Reporting Period. Subsequent Annual R eports shall be received by

the O IG no later than the anniversary date of the due date of the first Annua l Re port.

Each Annual R eport shall include:



A certification signed by K alous ek certifying that he is maintaining written

certifications fiom all Covered Persons that they received training pursuant

to the requirem ents set forth in Section 1II.D of this Agreement;

A complete copy of all reports prepared pu rsu aii ~o the IRO 's Billing

Engagement, including the Claims Review Report and S ystems Review

Report, along with a copy of the IRO's engagem ent letter;

Kalousek 's response an d corrective action plan(s) related to any issues

raised or recommendations made by the IRO;

A summary/description of all engagements between Ka lousek and the IRO,including, but not limited to, any outside financial audits, com pliance

program engagements, or reimbursement consulting, if different from what

was submitted as part of the Implementation Report;6

A certification from the IRO regarding its professional indep ende nce from

Kalousek;

A summary of Material D eficiencies (as defined in Se ction 1II.G) identified

during the Rep orting Period and the status of any corrective and preventative

action relating to all suc h Material Deficiencies;

A summary describiqg any ongoing investigation or legal proceeding

required to have been reported pursuant to Section 1II.H. Th e sum mary

shall include a description of the allegation, the identity o f the investigatingor prosecuting agency, and the status of such investigation or legal

proceeding;



VI. NOTIFICATIONSND SUBMISSIONF REPORTS

Unless o therwise stated in writing after the Effective Date, all notifications and

reports required under the terms of this Agreem ent shall be submitted to the following:

OIG:

Kalousek:

Adm inistrative and Civil Remedies Branch

Office of Counsel to the Inspector General

Office of Inspector General

U.S. Department of Health and Human Services

Cohen Building, Room 5527

3 30 Independence Avenue, S.W .W ashington, DC 2020 1

Telephone: 202.61 9.2078

Facsimile: 202.205.0604

Dr. G eorge KaIousek0

1 1287 Ranch Place

W estminster, CO 80234Teleph one: 303.426.6 15 1

Unless otherw ise specified, all notifications and reports required by this

Agree men t shall be ma de by certified mail, overnight mail, hand d elivery, or other

means, provided that there is proof that such notification was received. For purpo ses ofthis requirement, internal facsim ile confirmation sheets do not constitute proof o f receipt.

VII. OIG INSPECTION,UDITANDREVIEWRIGHTS

In addition to any other rights the OIG m ay have by statute, regulation, o r



authorized representative(s) in contacting and arranging interviews with su ch individualsupon the O IG's request. Kalousek's employees may elect to be interviewed with orwithout a representative of Kalousek present.

VIII. DOCUMENTNDRECORDRETENTION

Kalousek shall maintain for inspection all docum ents and records relating toreimbursem ent from the Federal health care programs, or to.comp liance with thisAgreem ent, for six years (or longer if otherwise required by law).

Consistent with HHS 's FOIA proc edures, set forth in 45 C.F.R . Part 5, the OIGshall make a reasonable effort to notify Kalousek prior to any release by O IG o finformation submitted by Kalousek pursuant to its obligations under this Agre em ent andidentified upon submission by Kalousek as trade secrets,@ornformation that iscomm ercial or financial and privileged or confidential, unde r the FOIA rules. With

respect to suc h releases, Kalousek shall have the rights set forth at 45 C.F.R. 5 5.65(d).Kalousek shall refrain from identifying any information as exemp t from release if thatinformation does not meet the criteria for exem ption from disclosure under FO IA.

X . BREACH ND DEFAULT ROVISIONS

Kalousek is expected to fi Ily and timely com ply with all of his A greementobligations.

A. Stipulated Penalties for Failure to Complv with Certain Obli~ations



c. implem ent and make available the Policies and Proceduresrequired in S ection 1II.C;

d. require that Covered Persons attend the training required bySec tion 1II.D with in the tim e fi-ames required in that S ection ;

e. retain an IRO within the timefiame required in SectionII1.F. 1, or to submit the IR O's annual Claim s Rev iew Report

and Process Review Report as required in Section 1II.F an d

Appendix A; or

f. meet any of the deadlines for the subm ission o f theImplementation Report or the Annual Reports to OIG.

2. A Stipulated Penalty of $750 (which shall be gi dt o accrue on the datethe failure to comply began) for each day Kalousek employs o r contracts with an

Ineligible Person and that person: (i) has responsibility for, or involv eme nt with,Kalousek's business operations related to the Federal health care progra ms ; or (ii) is in aposition for which the person 's salary or the items or services rendered, o rdered, orprescribed by the person are paid in whole or part, directly or indirectly, by Fede ralhealth care programs or otherwise with Federal k n d s (the S tipulated Penalty described inthis Paragraph shall not be demanded for any time period during wh ich Ka lousek ca ndemonstrate that Kalousek did not discover the person's exclusion or other ineligibility

after making a reasonab le inquiry (as described in S ection III.C.5) as to the sta tus o f theperson).

3. A Stipulated Penalty of $750 for each day K alouse k fails to grant acc ess ,



Kalouse k shall take to comply with the Agreem ent. (This Stipulated Penalty shall begin

to accrue 10 days after the date Kalousek receives notice fiom the O IG of the failure to

com ply.) A S tipulated Penalty as described in this Subsection shall not be demand ed for

any violation for which the O IG has sought a Stipulated Penalty under Subsections 1-3 ofthis Section.

B. Timely W ritten Requests for Extensions

Kalousek m ay, in adva nce of the du e date, subm it a timely written request for an

extension o f time to perform any act or file any notification or report required by this

Agreem ent. Notw ithstanding an y other provision in this Section, if the OIG gra nts thetimely w ritten request with respect to an act, notification, or report, Stipulated Penalties

for failure to perform the act or file the notification or report shall not begin to acc rue

until one day after Kalou sek fails to meet the revised deadline set by the OIG .

Notw ithstanding any other provision in this Section, if the OIG den ies such a timely

written request, Stipulated Penalties for failure to perform the act or file the notification

or report shall not begin to accrue until three business days after Kalousek receiv es the

OIG 's written d enial of such request or the original due date, wh ichev er is later.A

"timely written request" is defined as a request in writing received by the OI G at least

five business d ays prior to the date by which any act is due to be perfo rmed or anynotification or report is due to be filed.

C. Paym ent of Stipulated Penalties.

1 . Demand L etter. Upon a finding that Kalousek has failed to com ply with

any of the obligations described in Section X.A and afier determin ing that S tipulated

Penalties are approp riate, the OIG shall notify Kalousek of: (a) Kalouse k's failure to

comply; and (b) the OIG's exercise o f its contractual right to dem and payment of the



3 . Form of Payment. Paym ent of the Stipulated Penalties shall be made by

certified or cash ier's check, payable to: "Secretary of the Departm ent of Health and

Hum an Services," and sub mitted to the OIG at the address set forth in Se ction VI.

4. Independ encefiorn Material Breach Determination. Except as set forth

in Section X.D. 1 c, these provisions for paym ent o f Stipulated Penalties shall not a ffect

or otherwise set a standard for the OIG 's d ecision that Kalousek has m aterially breached

this Agreeme nt, which de cision shall be made at the OIG 's discretion and shall be

governed by the provisions in Section X.D, below. -D. Exclusion for Material Breach of this Agreement

1. Definition o f Material Breach. A material breach of this Agreement

means:

a. a failure by Kalouse k to report a M aterial D eficiency, take

corrective action and make the appropriate refunds, as requ ired inSection II1.F;

b. a repeated or flagrant violation of the obligations und er this

Agreem ent, including, but not limited to, the obligations addressed

in Section X.A;

c. a failure to respond to a Demand L etter con cerning the payment of

Stipulated Penalties in accordance with Section X.C; or

d. a failure to retain and use an Independent Review O rganiz ation in



3. Opportunity to Cur e. Kalousek shall have 30 days from the date of

receipt o f the Notice o f Material Breac h and Intent to Exclude to demonstrate to the

OIG 's satisfaction that:

a. Kalousek is in compliance with the obligations o f the Agreement

cited by the OIG as being the basis for the material breach;

b. the alleged material breach has been cured; or

c. the alleged material breach cannot be cured within the 30-day

period, but that: (i) Kalousek has begun to take action to cure thematerial breach; (ii) Kalousek is pursuing su ch action with due

diligence; and (iii) Kalousek has provided to the OIG a reasonable

timetable for cu ring the material breach.

4. Exclusion Letter. If at the conclusion of the 30-day period, Kalousek "

fails to satisfy the requirements o f Section X.D.3, the OIG may exclude Ka lousek from

participation in the Federal health care programs. The OIG shall notify Kalousek inwriting o f its determination to exclude K alousek (this letter shall be referred to

hereinafter as the "Exclusion Letter"). Subject to the Dispute Reso lution prov ision s in

Section X.E, below , the exclusion sh all go into effect 30 days after the date o f the

Exclusion Letter. The exclusion shall have national effect and shall also apply to all

other Federal procurement and nonprocurement programs. Reinstatem ent to program

participation is not automatic. If at the end of the period o f exclusio n, Kalo usek w ishes

to apply for reinstatement, Kalous ek shall submit a written request for reins tatem ent in

accordance with the provisions at 42 C .F.R. $5 100 1.3001-.3004.

E. Dispute R esolution



request for a hearing involving exclusion shall be made within 25 day s after receipt of the

Exclusion Letter.

2. Stipulated Penalties Review . Notwithstanding any provision of Title 42of the United States Code or C hapter 42 of the C ode of Federal Regulations, the only

issues in a proceeding for Stipulated Penalties under this Agreem ent shall be: (a) whe ther

Kalousek w as in full and timely com pliance with the obligations of this Agreement for

which the OIG dem ands payment; and (b) the period of noncompliance. Kalousek shall

hav e the burden o f proving its full and timely comp liance and the steps taken to cure the

noncompliance, if any. The OIG shall not have the right to appeal to the DA B an adverse

ALJ decision related to Stipulated Penalties. If the ALJ agrees with the OIG w ith regardto a finding of a breach of this Agreemen t and orders Kalousek to pay S tipulated

Penalties, such Stipulated Penalties shall become due and payable 20 days after the ALJ

issues such a decision unless Kalousek requests review of the ALJ decision by th e DA B.

If the ALJ decision is properly appealed to the DAB and the DA B upholds the

determination o f the O IG, the Stipulated Penalties shall become due and payable 2 0 daysafter the DAB issues its decision.

3 . Exclusion R eview. Notwithstanding any provision of Title 42 o f the

United S tates Cod e or Chapter 42 of the Code of Federal Regulations, the only issues in a

proceeding for exclusion based on a material breach of this Agreem ent shall be:

a. whether Kalousek w as in material breach of this Agreement;

b. whether such breach was continuing on the date of the ExclusionLetter; and

c. wheth er the alleged material breach could not have been cu red



determ ines that exclu sion is authorized, s uch exclusion shall take effect 20 day s after the

ALJ issues such a decision , notwithstanding that Kalousek m ay request review of the

ALJ decision by the DAB. If th e DAB finds in favor of the OIG after an ALJ decision

adverse to the OIG, the ex clusion sh all take effect 20 days after the DAB decision.Kalousek shall waive his right to any no tice of such an excl~isionf a decision uphold ing

the exclusion is rendered by the ALJ or DAB. If the DA B finds in favor of Kalousek,

Kalou sek shall be reinstated effective on the date of the original exclusion.

4. Finality of Decision. Th e review by an ALJ o r DA B provided for above

shall not be con sidered to be an app eal right arising under any statutes or regulations.

Consequently, the parties to this Agreement agree that the DAB 'S decision (or the A LJ'sdecision if not appealed) shall be conside red final for all purpo ses und er this Agree men t.

XI. EFFECTIVEND BINDING GREEMENT

Consistent with the provisions in the S ettlement Agreement pursuant to which this

Agreement is entered, and into which this Agreement is incorporated, Kalou sek and the

OIG agree as follows:

A, This Agreement shall be binding on the successors, assigns, and transfereesof Kalousek;

B. This Agreement shall becom e final and binding on the date the finalsignature is obtained on the Agreement;

C. Any modifications to this Agreement shall be mad e with the prior written

consent of the parties to this A greement;



health care program s. If Kalousek withdraws from participation in Federal

health care programs and is relieved fiom its Agreement obligations by the

OIG, Kalousek shall notify the OIG 30 days in advance of Kalousek 's

intent to reapp ly as a participating provider or supplier with the Federalhealth care program s. Upon receipt of such notification, the OIG shall

evaluate wheth er the Agreemen t shall be reactivated or modified.

F. Th e undersigned Kalou sek signatories represent and warrant that they are

authorized to execute this Agreement. The undersigned OIG signatory

represents that h e is signing this Agreem ent in his official capacity and that

he is authorized to execute this Agreement.



*ate

1 1287 Ranch Place

Westminster, CO 80234

-?/aRichard Kornfeld Date

Counsel for George Kalousek, M.D .



OFFICE F INSPECTOR GENERAL F THE DEPARTMENTFHEALTH ND HUMAN

SERVICES

d2*Larry J. Go1 l%erg, Esquire

Assistant Inspector General for Legal A ffairs

Office of Counsel to the Inspector GeneralOffice of Inspector General

U. S. Department of Health and Human Services



APPENDIX A

A. Bil ling Eng a~e me nt ' s l aims Review.

1 . Definitions. For the purposes of the Claims Review, the following definitions

shall be used:

a. Ove rpaym ent: Th e amount of money Kalousek has received in excess

of the amo unt due and payable under any Federal health care program

requirements.

b. Item: An y discrete unit that can be sampled(aode, line item,

beneficiary, patient encounter, etc.).

c. Paid Claim: A code or line item subm itted by Kalousek an d for which

Kalousek has received reimbursement from the Medicare progra m.

d. Population: All Items for which Kalousek has submitted a code or line

item and for which Kalousek has received reimbursement from the

Medicare program(k,Paid Claim) during the 12-month period covered

by the Claims Rev iew. T o be included in the Population, an Item must

have resulted in at least one Paid Claim.

e. Error Rate: Th e Error Rate shall be the percentage of net Overpay men ts

identified in the sam ple. Th e net Overpaym ents shall be calculated by

subtracting all underpayments identified in the s amp le from all gross

Overpaym ents identified in the sample. (Note: An y potential cost



2. Other Requirements.

a. Paid Claims without Supporting Documentation. For the purpose ofappraising Item s included in the Claims Review, any Paid C laim for which

Kalousek cannot produce documentation sufficient to support the PaidClaim shall be considered an error and the total reimbursement received by

Kalousek for such Paid Claim shall be deemed an Overpaym ent.

Replacem ent samp ling for Paid Claims with m issing documentation is not

permitted.

b. Use of First Samples Drawn. For the purposes of all samples (Discovery

Sam ple(s) and Full S ample(s)) discussed in this Appen dix, the Paid Claim s

associated with the Item s selected in each first sample (or first sample for

each strata, if applicable) shall be used. In other words, it is not permissible

to generate more than one list of random sam ples and then select one for

use with the Discovery Sample or Full Sam ple.

B. Claims Review Report. Th e following information shall be included in the

Claims Review R eport for each Discovery Sample and Full Sam ple (if applicable).

1. Claims Review Methodology.

a. Sam pling Unit. A description of the Item as that term is utilized for the

Claims Review.

b. ,Claims Review Population. A description of the Population subjec t to

the Claims Review.



orders, certificates of medical necessity, requisition form s, local medical

review policies, CM S program memoranda, M edicare carrier or

intermediary m anual o r bulletins, other policies, regulations, o r directives).

f. Review Protocol. A narrative description of how the Claim s Review

was conducted and what was evaluated.

2. Statist ical Sam pling Documentation.

a. The number of Items appraised in the Discovery S ample and, ifapplicable, in the Full Sam ple.

b. A copy of the printout of the random num bers generated by the

"Random Numbers" function of the statistical sampling s o h a r e used by

the IRO.

c.

A copy of the statistical software printout(s) estimating ho w m any Item sare to be included in the Full Sample, if applicable.

d. A description or identification of the statistical samp ling softw are

package used to conduct the sampling.

3. Claims Review Findings.

a. Narrative Results.

i. A description of Kalousek's billing and coding system (s),



b. Quantitative Results.

i. Total number and percentage of instances in which the IRO

determined that the Paid Claims submitted by Kalousek ("Claim

Subm itted") differed from what shou ld hav e been the correct claim

("Correct Claim"), regardless of the effect on the paym ent.

ii. Total numb er and percentage of instances in which the Claim

Submitted differed from the Correct Claim and in which suchdifference resulted in an Overpaym ent to Kalouse k.

iii. To tal dollar amount o f paid Item s included in the samp le and the

net Overpayment associated with the sam ple.

iv. Error Rate in the sample.

v . A spreadsheet of the Claims Review results that includes the

following information for each Paid Claim app raised: Federal health

care program billed, beneficiary health insurance claim number, date

of service, procedure co de subm itted, procedure code reimbu rsed,

allowed amount reimbursed by payor, correct procedure code (as

determined by the IRO), correct allowed am ount ( as determined by

the IRO), dollar difference between allowed am ount reimbursed by

payor and the correct allowed amount. (See Attachment 1 to this

Appendix.)



Attachment 1

Claim Review Results0

Federal

Health

CareProgram

Billed

Bene

HIC

#

Date of

Service

- --Procedure Procedure

Code Code

Submitted Reimbursed

Allowed

Amount

Reimbursed

Correct

Procedure

Code (1ROdetermined

Correct

Allowed

A1ntReimbursed

( I RO

determined)

Dollar

Difference

between AmtReimbursed and

Correct Allowed

Am t

George Kalousek, M.D.Integrity A greement



NOTICE -A

ATTACHMENT 2

Physician Organization AB C is committed to complying with all Federal health care program requirements in the operationof its business.

Anyone w ho has information or concerns about a possible violation o f A B C ' s policies and procedures or any Federal health

care program requirements should contact the C ompliance officer at (123) 456-7890 or via email at [email protected].

Reporting may also be made anonymously by sending correspondence to:

Steve Jones

Pfzysician Organization A BC

244 Circle Dr.

New Town, ST 10000

' Fax: (123 ) 436- 7788

George Kalousek, M.D.Integrity Agreement

Health and Human Services: George%20Kalousek%20MD%207%2023%202003

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