joint report on corporate practice of dentistry in the medicaid program july 2013
TRANSCRIPT
7/27/2019 Joint Report on Corporate Practice of Dentistry In The Medicaid Program July 2013
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U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON :
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COMMITTEE PRINT " !113TH CONGRESS 1st Session
S. PRT.
2013
113–16
JOINT STAFF REPORT ONTHE CORPORATE PRACTICE OF DENTISTRY
IN THE MEDICAID PROGRAM
PREPARED BY THE STAFF OF THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
M AX B AUCUS, Chairman
AND
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
CHUCK GRASSLEY , Ranking Member
JUNE 2013
Printed for the use of the Committee on Finance
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COMMITTEE ON FINANCE
MAX BAUCUS, Montana, Chairman
JOHN D. ROCKEFELLER IV, West VirginiaRON WYDEN, OregonCHARLES E. SCHUMER, New YorkDEBBIE STABENOW, MichiganMARIA CANTWELL, WashingtonBILL NELSON, FloridaROBERT MENENDEZ, New JerseyTHOMAS R. CARPER, DelawareBENJAMIN L. CARDIN, MarylandSHERROD BROWN, Ohio
MICHAEL F. BENNET, ColoradoROBERT P. CASEY, Jr., Pennsylvania
ORRIN G. HATCH, UtahCHUCK GRASSLEY, IowaMIKE CRAPO, IdahoPAT ROBERTS, KansasMICHAEL B. ENZI, Wyoming JOHN CORNYN, TexasJOHN THUNE, South DakotaRICHARD BURR, North CarolinaJOHNNY ISAKSON, GeorgiaROB PORTMAN, Ohio
PATRICK J. TOOMEY, Pennsylvania
A MBER COTTLE, Staff DirectorCHRIS C AMPBELL, Republican Staff Director
COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
DIANNE FEINSTEIN, CaliforniaCHARLES E. SCHUMER, New YorkDICK DURBIN, IllinoisSHELDON WHITEHOUSE, Rhode Island
AMY KLOBUCHAR, Minnesota AL FRANKEN, MinnesotaCHRISTOPHER A. COONS, Delaware
RICHARD BLUMENTHAL, ConnecticutMAZIE HIRONO, Hawaii
CHUCK GRASSLEY, IowaORRIN G. HATCH, UtahJEFF SESSIONS, AlabamaLINDSEY GRAHAM, South CarolinaJOHN CORNYN, TexasMICHAEL S. LEE, UtahTED CRUZ, Texas
JEFF FLAKE, Arizona
BRUCE A. COHEN, Chief Counsel and Staff DirectorK OLAN D AVIS, Republican Chief Counsel and Staff Director
(II)
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(III)
C O N T E N T S
Page
I. Preface ............................................................................................................ 1II. Executive Summary ....................................................................................... 1
A. CSHM ....................................................................................................... 2B. ReachOut Healthcare America ............................................................... 3
III. Key Findings .................................................................................................. 6IV. Church Street Health Management and Small Smiles Dental Centers 7
A. Corporate Structure ................................................................................ 8B. The Influence of Private Equity ............................................................. 11C. Federal Government Intervention ......................................................... 12D. Committee Staff Site Visit to Small Smiles of Oxon Hill, Maryland .. 13E. CSHM Repeatedly Fails to Meet Quality and Compliance Stand-
ards ............................................................................................................. 171. Phoenix, Arizona Independent Monitor Report .............................. 172. Manassas, Virginia Independent Monitor Report .......................... 183. Oxon Hill, Maryland Small Smiles Clinic ...................................... 204. Oxon Hill, Maryland Small Smiles Overpayment .......................... 215. Youngstown, Ohio Clinic .................................................................. 21
F. Health and Human Services Office of Inspector General Notice of Intent to Exclude ....................................................................................... 22
G. Continuation of Abuses Following the Health and Human ServicesOffice of Inspector General Notice of Intent to Exclude and NewOwnership .................................................................................................. 26
1. Florence, South Carolina Independent Monitor Report ................ 272. Lynn, Massachusetts Independent Monitor Report ....................... 283. Mishawaka, Indiana Independent Monitor Report ........................ 284. Colorado Springs, Colorado Independent Monitor Report ............. 29
V. Dental Demographics .................................................................................... 30 VI. Recommendations .......................................................................................... 32
Appendix ............................................................................................................... 35Exhibit 1 ........................................................................................................ 35Exhibit 2 ........................................................................................................ 40Exhibit 3 ........................................................................................................ 74Exhibit 4 ........................................................................................................ 142Exhibit 5 ........................................................................................................ 158Exhibit 6 ........................................................................................................ 162Exhibit 7 ........................................................................................................ 188Exhibit 8 ........................................................................................................ 194Exhibit 9 ........................................................................................................ 204Exhibit 10 ...................................................................................................... 211Exhibit 11 ...................................................................................................... 254Exhibit 12 ...................................................................................................... 279Exhibit 13 ...................................................................................................... 297Exhibit 14 ...................................................................................................... 301Exhibit 15 ...................................................................................................... 307Exhibit 16 ...................................................................................................... 350
Exhibit 17 ...................................................................................................... 397Exhibit 18 ...................................................................................................... 425Exhibit 19 ...................................................................................................... 427Exhibit 20 ...................................................................................................... 429Exhibit 21 ...................................................................................................... 453Exhibit 22 ...................................................................................................... 459Exhibit 23 ...................................................................................................... 469Exhibit 24 ...................................................................................................... 504Exhibit 25 ...................................................................................................... 509
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Appendix—ContinuedExhibit 26 ...................................................................................................... 523Exhibit 27 ...................................................................................................... 535Exhibit 28 ...................................................................................................... 591Exhibit 29 ...................................................................................................... 594Exhibit 30 ...................................................................................................... 605Exhibit 31 ...................................................................................................... 612Exhibit 32 ...................................................................................................... 622Exhibit 33 ...................................................................................................... 638Exhibit 34 ...................................................................................................... 668Exhibit 35 ...................................................................................................... 684Exhibit 36 ...................................................................................................... 714Exhibit 37 ...................................................................................................... 720Exhibit 38 ...................................................................................................... 722Exhibit 39 ...................................................................................................... 752Exhibit 40 ...................................................................................................... 789Exhibit 41 ...................................................................................................... 816Exhibit 42 ...................................................................................................... 842Exhibit 43 ...................................................................................................... 881Exhibit 44 ...................................................................................................... 1027Exhibit 45 ...................................................................................................... 1032Exhibit 46 ...................................................................................................... 1040Exhibit 47 ...................................................................................................... 1063Exhibit 48 ...................................................................................................... 1088Exhibit 49 ...................................................................................................... 1115Exhibit 50 ...................................................................................................... 1139Exhibit 51 ...................................................................................................... 1161Exhibit 52 ...................................................................................................... 1189Exhibit 53 ...................................................................................................... 1210Exhibit 54 ...................................................................................................... 1248Exhibit 55 ...................................................................................................... 1267Exhibit 56 ...................................................................................................... 1291Exhibit 57 ...................................................................................................... 1331Exhibit 58 ...................................................................................................... 1337Exhibit 59 ...................................................................................................... 1340Exhibit 60 ...................................................................................................... 1343Exhibit 61 ...................................................................................................... 1427Exhibit 62 ...................................................................................................... 1438Exhibit 63 ...................................................................................................... 1450Exhibit 64 ...................................................................................................... 1475Exhibit 65 ...................................................................................................... 1500Exhibit 66 ...................................................................................................... 1509
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(1)
I. Preface
The United States Senate Committee on Finance has jurisdictionover the Medicare and Medicaid programs. As the Chairman anda senior member and former Chairman of the Committee, we havea responsibility to the more than 100 million Americans who re-ceive health care coverage under these programs to oversee theirproper administration and ensure the taxpayer dollars are appro-priately spent. This report describes the investigative work, find-ings, and recommendations of the Minority Staff of the SenateCommittee on the Judiciary and the Majority Staff of the Senate
Committee on Finance regarding the corporate practice of dentistryin the Medicaid program. The issues are analyzed primarily in thecontext of one company, Small Smiles. We received whistleblowercomplaints about the company, it has been the subject of a FalseClaims Act lawsuit, and it has been under a corporate integrityagreement with independent monitoring by the Department of Health and Human Services Office of Inspector General since Jan-uary 2010. In addition, we briefly examined complaints received re-garding ReachOut Healthcare America (ReachOut).
At the outset of this investigation, Church Street Health Man-agement (CSHM), the parent company of Small Smiles, cooperatedwith Committee staff until it emerged from bankruptcy. Afteremerging from bankruptcy and hiring new counsel, CSHM ceasedcooperating. Under the old ownership, Committee staff was able toobtain reports by the Independent Monitor, a private, independent
oversight entity whose services were mandated as part of CSHM’ssettlement agreement with the U.S. Department of Justice (DOJ).However, the new owners and counsel refused to give Committeestaff access to on-going reports from the Independent Monitor.ReachOut cooperated with the Committees’ investigation. Morethan 10,000 pages of documents were obtained from CSHM,ReachOut, whistleblowers, and Federal entities. The Committeestaff conducted six meetings with Small Smiles, six meetings withthe U.S. Department of Health and Human Services Office of In-spector General, one site visit, and various stakeholder meetingsthroughout the course of the investigation. Likewise, the Com-mittee staff met with ReachOut three times in addition to meeting with various stakeholders.
II. Executive Summary
Across the country, there are companies that identify themselvesas dental management companies. These organizations are typi-cally organized as a corporation or limited liability company. Theywork with dentists in multiple states and purport to provide gen-eral administrative management services. In late 2011, whistle-blowers and other concerned citizens came forward with informa-tion that some of these companies were doing more than providing
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management services. In some cases, dental management compa-nies own the dental clinics and have complete control over oper-ations, including the provision of clinical care by clinic dentists.
While there is no Federal requirement that licensed dentists,rather than corporations, own and operate dental practices, manystates have laws that ban the corporate practice of dentistry. Inthose states where owners of dental practices must be dentists li-censed in that state, the ownership structure used by some dentalmanagement companies is fundamentally deceptive. It hides fromstate authorities the fact that all rights and benefits of ownershipactually flow to a corporation through contracts between the com-pany and the ‘‘owner dentist.’’ These contracts render the ‘‘ownerdentist’’ an owner in name only.
Notably, these clinics tend to focus on low-income children eligi-ble for Medicaid. However, these clinics have been cited for con-ducting unnecessary treatments and in some cases causing serioustrauma to young patients; profits are being placed ahead of patientcare.
In one case, the corporate structure of a dental managementcompany appears to have negatively influenced treatment decisionsby over-emphasizing bottom-line financial considerations at the ex-pense of providing appropriate high-quality, low-cost care. As aconsequence, children on Medicaid are ill-served and taxpayerfunds are wasted.
Our investigation into these allegations began by examining fivecorporate dental chains which were alleged to be engaged in thesepractices:
• Church Street Health Management (CSHM), which at the timeowned 70 Small Smiles dental clinics in 22 states and the Dis-trict of Columbia;
•
NCDR, LLC, which owns 130 Kool Smiles clinics in 15 statesand the District of Columbia;• ReachOut Healthcare America (ReachOut) which operates mo-
bile clinics that treat children at schools in several states;• Heartland Dental Care, Inc. (Heartland), which operates more
than 300 clinics in 18 states; and• Aspen Dental Management, Inc., (Aspen) which operates more
than 300 Aspen Dental clinics in 22 states.
While we initially looked broadly at all five companies, the focusshifted primarily to CSHM and ReachOut, due to similarities be-tween the patient populations of these two companies. Both treatMedicaid-eligible children almost exclusively and therefore are re-imbursed using taxpayer dollars.
A. CSHM
CSHM has management services agreements with dental clinicswhich extend far beyond providing typical management services.Through its agreements, CSHM assumes significant control overthe practice of dentistry in Small Smiles clinics and is empoweredto take substantially all of a clinic’s profits.
CSHM has management services agreements with ‘‘owner den-tists’’ who typically work at one of the Small Smiles clinics and also‘‘own’’ several clinics nearby. These ‘‘owner dentists’’ are paid a sal-
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1 Interview with Stacey Gagnon, by Moriarty Leyedecker, PC at 2 (Nov. 11, 2011) (Exhibit 36).2See id.3See id. at 3.4Letter from Reginald Brown, Attorney at WilmerHale, to Senators Baucus and Grassley at
5 (Feb. 23, 2012) (Exhibit 31).5 Interview with Stacey Gagnon, by Moriarty Leyedecker, PC at 4 (Nov. 11, 2011) (Exhibit 36).6See id. at 5.7See id. at 4.
ary by CSHM as well as a flat fee when they sign state paperworkdeclaring that they own other clinics. In a glaring departure fromindustry practice, some ‘‘owner dentists’’ have never visited clinicsthat they purport to own, are not allowed to make hiring decisions,and do not even control the scheduling of patients. Moreover, SmallSmiles dentists are required by their parent company, CSHM, totreat a high volume of patients daily, which subsequently has a sig-nificant impact on the quality of care delivered.
Defenders of this corporate structure are quick to claim thatwithout their organizations, the under-served Medicaid populationwould not have access to dental care. Countless news reports citelow Medicaid reimbursement rates as the principal cause for thelack of access to dental care for low-income families. However, if states and Medicaid are having difficulty recruiting good dentiststo serve such a vulnerable population due to lack of reimburse-ment, how are private investors so successful at producing huge
profits from those allegedly inadequate Medicaid reimbursements?Do short-term profits come at the cost of quality care and a sus-tainable business model in the long run? Local dentistry practicesshould be able to provide quality care to the Medicaid populationand still be profitable. Fortunes should not be made on Wall Streetby sacrificing proper care for the underprivileged.
B. ReachOut Healthcare America
The troubling case of Isaac Gagnon illustrates the concerns relat-ing to the quality of ReachOut’s care and a pattern of treatmentwithout parental consent. A then 4-year-old ‘‘medically fragile’’ boy,Isaac received invasive dental work in October 2011 from a mobileservices unit that held a contract with ReachOut Healthcare Amer-ica.1 Notably, Isaac’s mother said that while she permittedReachOut to review dental hygiene education with Isaac, she also
expressed her wishes that no procedures be performed.2 On the day treatment was provided, the mobile dental unit vis-ited Isaac’s special needs preschool. During treatment that lastedapproximately 40 minutes, three adults held down a screaming,kicking, and gagging Isaac.3 This disturbing conduct violatedReachOut’s own internal policy that a patient is never to be phys-ically restrained in any manner, except by holding a patient’shands when the patient ‘‘presents [an] imminent danger of harmto themselves.’’ 4 In the aftermath, Isaac was severely traumatized,and according to his mother, a ‘‘complete mess, emotionally.’’ 5 Moreover, since the treatment, Isaac has exhibited increasingly ag-gressive behavior—namely, kicking, screaming, and punching.6
Ultimately, after Isaac’s mother informed the school super-intendent, the school board voted to sever contractual ties withReachOut, and issued a cease and desist order.7 Isaac’s mother was
referred to a pediatric dentist who concluded after examining Isaac
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8See id.9See Ken Alltucker, Mobile dental clinics drawing scrutiny, AZCentral.com (Aug. 18, 2012)
http://www.azcentral.com/business/articles/20120810mobile-dental-clinics-scrutiny.html.10 Id.11See, e.g., Administrative Agreement between ReachOut and [REDACTED] DDS, PC (July
2, 2006) (bates RHA 0000007–0000021) (Exhibit 32).12 Administrative Agreement between ReachOut and [REDACTED], DDS at 9 (Apr. 23, 2009)
(bates RHA 0000030) (Exhibit 33). Small Smiles has what is arguably similar language to thatfound in ReachOut’s administrative agreement. However, ReachOut’s language appears to be fo-cused more on limiting its liability. Moreover, our investigation found that Small Smiles’ con-tractual language is at odds with actual practice. See report Section IV(a); see ManagementServices Agreement, Small Smiles Dentistry for Children, Albuquerque, PC and FORBA, LLCat 2 (Oct. 1, 2010) (Exhibit 6).
13See Administrative Agreement between ReachOut and Big Smiles Colorado at 2–3 (July 1,2009) (bates RHA 0000051–0000065) (Exhibit 34).
14See Letter from Reginald Brown, Attorney at WilmerHale, to Senators Baucus and Grassleyat 2 (Feb. 23, 2012) (Exhibit 31).
15See id.
that the two pulpotomies (root canals) and two silver crowns ad-ministered were both unnecessary, and in the case of the former,performed incorrectly.8
Another troubling case occurred in December 2011. Nevada’sClark County School District, with a student population of almost400,000, severed contractual ties with ReachOut after receiving complaints from parents who alleged ReachOut did not give propernotification before proceeding with serious procedures such as fill-ings and crowns.9 According to Amanda Fulkerson, spokespersonfor the Clark County School District, ‘‘They [ReachOut] were going well beyond what we consider preventive care.’’ 10
The allegations against ReachOut that its dental practices wereabusing children and billing Medicaid for unnecessary procedureswere serious and disturbing, but we found that those practiceswere not necessarily widespread. Unlike CSHM, ReachOut’s man-agement services agreements truly provide only administrative and
scheduling support, and do not constitute de facto ownership andcontrol of its mobile dental clinics.11
In its Administrative Agreements with dentists, ReachOut useslanguage similar to the following example, which ensures that thesole authority to practice dentistry remains with the licensed den-tist:
Sole Authority to Practice. Notwithstanding any other provisionof this Agreement, Provider shall have exclusive authority andcontrol over the healthcare aspects of Provider and its practiceto the extent they constitute the practice of a licensed profes-sion, including all diagnosis, treatment and ethical determina-tions with respect to patients which are required by law to bedecided by a licensed professional.12
ReachOut maintains administrative services agreements withlocal dentists, or principal shareholders (PCs), who largely providemobile services to schools, but also the military and in some states,nursing homes.13 At the time of this report, ReachOut has con-tracts with 23 dental practices in 22 states. The contracts betweenReachOut and dental practices relate only to nonclinical aspects.14 ReachOut is paid set fees by the dentists for facilitating the mobiledentistry services. These services include providing equipment andsupplies, maintaining inventory, and providing information sys-tems, financial planning, scheduling, reporting, analysis, and cus-tomer service.15
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16 Administrative Agreement between ReachOut and [REDACTED] DDS, PC at 1 (July 2,2006) (bates RHA 0000007–0000021) (emphasis added) (Exhibit 32).
17See id. at 9.18See id.19 Administrative Agreement between ReachOut and [REDACTED] D.D.S., Big Smiles Mary-
land PC, at 5 (Apr. 1, 2009) (bates RHA 0000246) (Exhibit 35).
The basic plan behind the Administrative Agreement betweenReachOut and the mobile dentists is ‘‘to provide administrative and financial services as set forth herein, so that the PC can focus on furnishing high-quality dental care directly and through third-party dentists to needy, primarily low-income, children in schoolsand out-of-home placement agencies needing mobile dentistrythrough the services of the PC’s dentist(s).’’ 16 The compensation forReachOut is divided into two categories: direct expenses and ad-ministrative services. Administrative services are billed at a fee of $500 per visit for all services provided.17 Direct expenses are billedat the actual cost plus 15% of the entire professional corporation(PC)’s employee salaries and expenses paid from the PC’s ac-count.18
Before children can receive treatment during school hours, theymust obtain parental approval. ReachOut America maintains thatall offered services must be pre-approved by the child’s parents or
legal guardians. Verification of the legal guardianship of the childis the responsibility of the school. However, per contractual agree-ment, ReachOut facilitates the delivery of the Provider consentforms and coordinates the completion of the consent forms:
• Arrange for the delivery of the Provider consent forms to theproper school employee in each school for each student to takehome.
• Coordinate that each school obtains completed consent formsby the students and that they are provided to the Adminis-trator [ReachOut].19
In ReachOut’s case, the reported problems of unnecessary proce-dures, lack of parental consent, and patient abuse appear to be theresult of ReachOut having management agreements with severalunscrupulous dentists. Given the administrative nature of their ar-
rangement, ReachOut lacks ability to police such bad actors. As of last year, the company had no standards for dentists with whomthey contract to obtain parental consent for treatment—leaving each mobile clinic to devise its own forms and procedures. Whilethese factors appear to have contributed to many of the problemsreported to us involving the company, it is also evidence thatReachOut does not significantly control the operations of clinic den-tists, and simply contracts with dentists to provide support serv-ices.
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III. Key Findings1. Through management services agreements with dentists,
CSHM is the de facto owner of all Small Smiles clinics. It retainsall the rights of ownership, employs all staff, recruits all staff,makes all personnel decisions, and receives all income from eachSmall Smiles clinic.
2. CSHM entered into a Corporate Integrity Agreement (CIA)with the U.S. Department of Health and Human Services (HHS)Office of Inspector General (OIG) as part of the company’s settle-ment with the U.S. Department of Justice (DOJ). As part of theagreement, an Independent Monitor (IM) conducts extensive auditsof CSHM’s clinics. During the last 3 years, the IM has found mas-sive amounts of taxpayer dollars being recklessly spent on unneces-sary procedures on children in the Medicaid program by SmallSmiles clinics.
3. After 2 years of intense scrutiny by HHS OIG through theCIA, and attempting to follow newly prescribed rules, CSHM wentbankrupt.
4. After 3 years of monitoring by the HHS OIG and emerging from bankruptcy with new ownership and leadership changes,CSHM has repeatedly failed to meet quality and compliance stand-ards set forth in the CIA with HHS OIG. Breaches in quality andcompliance include: (1) unnecessary treatment on children; (2) im-proper administration of anesthesia; (3) providing care withoutproper consent; and (4) overcharging the Medicaid program.
5. Despite CSHM’s repeated violations of the CIA, resulting inboth monetary fines and an HHS OIG-issued Notice of Intent toExclude the company from Medicaid, HHS OIG has allowed SmallSmiles to continue to participate in the program.
6. Despite state laws against the corporate practice of dentistry,
numerous states have allowed companies such as CSHM to operatedental clinics under the guise of management services agreements.These practices appear contrary to the purpose of state law requir-ing clinics to be owned and operated by licensed dentists. The re-sult is poor quality of care, billing Medicaid for unnecessary treat-ment, and disturbing consumer complaints.
7. Access to dental care is a problem in certain parts of the coun-try, particularly rural areas for the dual reasons of fewer employ-ment opportunities and lower reimbursement rates than urbancounterparts. It is also a problem for some patients served by theMedicaid program due to the number of dentists who are unwilling to accept patients on Medicaid. Access is complicated by the burdenof extremely high student loans of dentists graduating from dentalschool that makes serving rural or Medicaid populations problem-atic.
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20 Articles of Incorporation of FORBA, Inc., Secretary of the State of Colorado, signed by DanDeRose (Feb. 9, 2001) (Exhibit 1).
21See Small Smiles History, http://www.smallsmiles.com/small-smiles-history.php (last vis-ited Mar. 22, 2013).
22Press Release, Arcapita, Arcapita Completes Largest US Corporate Transaction (Jan. 15,2007) (http://www.arcapita.com/media/press l releases/2007/01–15–07.html); Sydney P. Freed-berg, Dental Abuse of U.S. Poor Dodges Ejection from Medicaid, BLOOMBERGBUSINESSWEEK ,June 26, 2012, http://www.businessweek.com/printer/articles/268590?type=bloomberg; Dr. Ste-ven Adair Joins FORBA Dental Management as Chief Dental Officer, BUSINESS WIRE, Sept. 19,2008 (on file with author).
23
See Small Smiles FAQs, http://www.smallsmiles.com/faqs.php (last visited Mar. 22, 2013).24 I–Team: Small Smiles Investigation, http://www.youtube.com/watch?v=pIoMaw4zC9Q (lastvisited Mar. 22, 2013).
25See B ALLENTINE’S L AW DICTIONARY (2010) (‘‘An action to recover a penalty brought by aninformer in the situation where one portion of the recovery goes to the informer and the otherportion to the state’’).
26Civil Settlement Agreement, FORBA and Dep’t of Justice (Jan. 15, 2010) (Exhibit 2).27 Interview with Tony West, Acting Associate Attorney General, Department of Justice, in
Washington, D.C. (Mar. 18, 2013) (on file with authors).28Corporate Integrity Agreement, Department of Health and Human Services and FORBA
Holdings, LLC (Jan. 15, 2010) (Exhibit 3).
IV. Church Street Health Management andSmall Smiles Dental Centers
Church Street Health Management was the successor company of an organization called FORBA (For Better Access). FORBA wasfounded in Pueblo, Colorado on February 9, 2001 by Dan DeRose.20
At the time of incorporation, FORBA operated only a handful of Small Smiles clinics in Colorado and New Mexico.21 Eventually,the company grew and expanded to a nationwide chain with morethan 60 clinics, and benefitted from an influx of private equity dol-lars, including investments by The Carlyle Group and Arcapita.22 Today, Small Smiles’ mission is ‘‘to provide the highest quality den-tal care to low-income children in the Medicaid and [S]CHIP popu-lations.’’ 23
An investigative report in 2008 by the ABC–7 I–Team in Wash-ington, DC revealed serious abuses at Small Smiles clinics. Fea-tured clinics prohibited parents from accompanying their childrenduring treatments and excessively used a device called a papooseboard, which is used to strap down young patients and immobilizethem during treatment. The clinics performed a high number of crowns and pulpotomies on children who did not require such ag-gressive treatment and engaged in improper X-ray billing. Thequality of care was significantly below any recognized medicalstandard according to independent pediatric dentists interviewedby ABC–7.24
This explosive report was triggered by several qui tam actions 25 initiating the investigations by the Department of Justice and theDepartment of Health and Human Services Office of Inspector Gen-eral.26 Acting Associate Attorney General Tony West went so far asto describe the conduct of Small Smiles as ‘‘really horrific stuff,’’
and further stated, ‘‘[T]he behavior in that [clinic] was so egregiousthat we had to—I think we were compelled to be very aggressiveabout going after [the] fraud in that case.’’ 27 The company eventu-ally settled with the government and entered into a CIA, whichprovided for extensive audits by an Independent Monitor.28 OnFebruary 20, 2012, after struggling to comply with the CIA, ChurchStreet Health Management filed for Chapter 11 Bankruptcy protec-
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29Bankruptcy Filing, Case 3:12–bk–01573 (Feb. 2, 2012) (Exhibit 4).30Letter from Theodore Hester, Attorney at King & Spalding, to Senators Baucus and Grass-
ley (Nov. 29, 2011) (Exhibit 5).31See, e.g., Consent Order Granting Permanent Inj. at 4, N.C. State Bd. of Dental Exam’rs
v. Heartland Dental Care, Inc., 11 CVS 2343 (N.C. Gen. Court of Justice Super. Ct. Div. 2011)(rescinding the Management Services Agreements between Heartland and Drs. Cameron & Son)(Exhibit 61).
32
See Appendix A. See generally Jim Moriarty, Survey of State Laws Governing the Corporate Practice of Dentistry, Moriarty Leyendecker 2012, at 10–11, http://moriarty.com/content/documents/ML l PDFs/cpmd l 4.10.12.pdf.
33See Management Services Agreement, Small Smiles Dentistry for Children, Albuquerque,PC and FORBA, LLC at 8 (Oct. 1, 2010) (Exhibit 6). (‘‘Gross Revenues shall mean all fees andcharges recorded or booked on an accrual basis each month by or on behalf of Practice as a re-sult of dental services furnished to patients by or on behalf of [dental] Practice as a result of dental services furnished to patients by or on behalf of [dental] Practice or the Clinic, less areasonable allowance for uncollectable accounts, professional courtesies and discounts.’’).
34See id. (emphasis added).35 Id. at 9.
tion.29
The company emerged from bankruptcy under the monikerCSHM, which is how we will generally refer to the company in thisreport.
A. Corporate Structure
CSHM argues that it does not own any dental clinics, but ratherthat it has management services agreements with dentists whoown the clinics.30 However, courts have voided management serv-ices agreements with similar characteristics to the agreements be-tween CSHM and their dental clinics.31 Based on our review of sev-eral management services agreements, employment contracts, andthe payment structure, it appears that these arrangements are de-signed to give the appearance of complying with state laws requir-ing that dental clinics be owned by licensed dentists.32 However, inpractice, dental clinics are not owned by dentists in any meaningful
sense.Typically, an agreement between the owner of a business and athird-party management company would simply involve the busi-ness owner paying a fee to the management company in return forservices. The arrangements between CSHM and its dental centers,however, are much more complex. Like traditional third-partymanagement agreements, dental clinics are obligated to pay CSHMa management fee under the terms of their management agree-ments. However, in that the benefits of the dental operations areheavily weighted toward CSHM, this fee is unlike traditionalagreements on account of the sheer asymmetry benefitting CSHM.Specifically, each calendar month, a dental clinic must pay CSHMthe greater of: (i) $175,000; or (ii) 40% of the ‘‘Gross Revenues’’; 33 or (iii) 100% of the ‘‘Residual.’’ 34 ‘‘Residual’’ is defined as ‘‘theGross Revenues and income of any kind derived, directly or indi-
rectly, from the Business . . . based on the net amount actually col-lected after taking into account all refunds, allowances, and dis-counts.’’ Notably, ‘‘residual’’ excludes ‘‘owner dentist’’ or staff com-pensation and benefits (and other expenses).35 Therefore, at a min-imum for any given month, CSHM is collecting a $175,000 manage-ment fee from dental clinics, even if the clinic loses money. How-ever, for banner months CSHM is poised to reap 100% of a clinic’sgross revenues and income, minus ‘‘owner dentist’’ and staff sala-ries and benefits.
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36Letter from Graciela M. Rodriquez, Attorney at King & Spalding, to Senators Baucus andGrassley (Dec. 16, 2011) (Exhibit 7).
37See Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles ClinicOxon Hill, Md. (Mar. 7, 2012).
38See id.39See id.40See Letter from Graciela M. Rodriquez, Attorney at King & Spalding, to Senators Baucus
and Grassley (Dec. 16, 2011) (Exhibit 7).41 Id; see, e.g., CSHM/Small Smiles Dentistry for Children, Albuquerque, PC, Buy-Sell Agree-
ment with [REDACTED] at 1 (Oct. 1, 2010) (CSHM–00000950) (Exhibit 8).42CSHM/Small Smiles Dentistry for Children, Albuquerque, PC, Buy-Sell Agreement with
[REDACTED] at 1 (Oct. 1, 2010) (CSHM–00000950) (Exhibit 8).43
CSHM/Small Smiles Dentistry for Children, Albuquerque, PC, Buy-Sell Agreement with[REDACTED] at 2–3 (Oct. 1, 2010) (CSHM–00000950) (Exhibit 8).44See id. at 3 (‘‘involuntary transfer’’ is an event ‘‘in which Owner shall be deprived or di-
vested of any right, title or interest in or to any Ownership Interest, including, without limita-tion, upon the death of Owner, transfer in connection with marital divorce or separation pro-ceedings, levy of execution, transfer in connection with bankruptcy, reorganization, insolvencyor similar proceedings. . . .’’).
45See Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles ClinicOxon Hill, Md. (Mar. 7, 2012); see, e.g., CSHM/Small Smiles Dentistry for Children, Albu-querque, PC, Buy-Sell Agreement with [REDACTED] at 2–3 (Oct. 1, 2010) (CSHM–00000950)(Exhibit 8).
According to a December 2011 letter from CSHM, ‘‘owners typi-cally pay themselves a fixed administrative fee from the practicesthey own.’’ 36 However, when Senate staff interviewed a SmallSmiles ‘‘owner dentist,’’ a different story emerged. After claiming that she owned five clinics in Maryland and Virginia, theinterviewee stated that she was paid a flat fee by the company, asopposed to paying herself a fixed administrative fee.37 Claiming that she had no input in choosing the amount of said fee, the‘‘owner dentist’’ further indicated she did not know if she was enti-tled to additional payments based on the number of clinics she sup-posedly owned, but was currently receiving one flat fee as if sheowned only one clinic.38 When asked why she chose to tell state au-thorities that she owned additional clinics for no additional com-pensation, the ‘‘owner dentist’’ stated that CSHM told her the clin-ics would close if someone else could not be found to list as the
owner.39
This arrangement is in direct contradiction to the rep-resentations made by CSHM in its December 16, 2011, letter toSenators Grassley and Baucus.40
At Small Smiles, ‘‘owner dentists’’ enjoy none of the traditionalbenefits normally associated with ownership. The ‘‘owner dentist’’has no equity in the practice in any meaningful sense of the word.
According to the Buy-Sell Agreement, CSHM can replace the‘‘owner dentists’’ at will, and the ‘‘owner dentist’’ has no right tosell the practice without consent from CSHM.41 Furthermore, theBuy-Sell Agreement states that should an Event of Transfer occur,a Small Smiles representative is then entitled to buy all of the‘‘owner dentist’s’’ ownership interests.42 Event of Transfer includes(but is not limited to) the following: owner’s death, owner’s loss of license to practice dentistry, owner’s ineligibility to participate inMedicare or Medicaid, loss of owner’s professional liability insur-ance, or owner’s termination or end of employment with CSHM orSmall Smiles.43 In the event of an Event of Transfer or InvoluntaryTransfer,44 the ‘‘owner dentist’’ is only entitled to the purchaseprice of $100.45 Notably, pursuant to stock pledge agreements withCSHM, ‘‘owner dentists’’ are prohibited from issuing additionalshares of capital stock in the dental clinic without first obtaining
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46CSHM/Small Smiles Dentistry for Children, Albuquerque, PC, Stock Pledge Agreement with[REDACTED] at 3 (Oct. 1, 2010) (CSHM–00000959) (Exhibit 65).
47See id.48See Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles Clinic
Oxon Hill, Md. (Mar. 7, 2012).49
See, e.g., e-mail from Dr. [REDACTED] to Dr. [REDACTED] (May 19, 2011, 4:57 pm) (Ex-hibit 9).50 Id.; see also Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles
Clinic Oxon Hill, Md. (Mar. 7, 2012).51MIC Memorandum, FORBA, LLC, Arcapita at 6 (June 2006) (FORBA l 0046011) (Exhibit
10) (emphasis added). Arcapita was the private equity firm that owned FORBA, LLC.52Corporate Integrity Agreement Between the Office of Inspector Gen. of the Dep’t of Health
& Human Serv. and Forba Holdings, LLC, at 13–14 (Jan. 14, 2010) (Exhibit 3).53 Id. at 10–11.54 Id. at 11–12.55 Id. at 8.
CSHM’s discretionary express written consent.46
Additionally,‘‘owner dentists’’ may also not amend, alter, terminate or supple-ment the clinic’s Articles of Incorporation, corporate Bylaws, and/ or other vital documents without first obtaining CSHM’s expresswritten consent.47
All lease agreements for the clinic buildings, property, and equip-ment are with CSHM, not the ‘‘owner dentist.’’ 48 The ‘‘owner den-tist’’ cannot determine the schedule or number of patients that theyor their dentists see each day.49 Furthermore, the ‘‘owner dentist’’cannot hire or fire employees or purchase new equipment withoutreceiving approval from CSHM.50
The purpose of these arrangements is made abundantly clear ina 2006 memorandum assessing CSHM’s (formerly FORBA) value:
Due to the state regulations prohibiting the corporate practiceof dentistry, FORBA does not technically provide dental care tothe patient, own any interest in its affiliated practices, or em-ploy the dentists in the clinic. However, FORBA selects thenew sites, negotiates the lease, oversees construction of theclinics, purchases the equipment, installs the IT and billing in-frastructure, employs the staff, recruits the dentists and re-ceives all of the income. Thus, it effectively owns and managesthe clinics.51
Thus, by this description, it is clear that the dental managementcompany actually maintains ownership and control over SmallSmiles clinics. Moreover, the facts and circumstances surrounding the creation and implementation of the CIA illustrate that this par-ticular ownership structure undermined the independent, profes-sional, and clinical judgment of Small Smiles dentists. That is pre-cisely the harm that state laws requiring that dentists own dentalpractices are designed to prevent.
In addition to the many other ways that CSHM limits the exer-cise of professional judgment by its dentists, the CIA requiresCSHM to ensure compliance with quality of care standards,52 per-form regular audits,53 and establish, implement, and distribute aCode of Conduct articulating consequences for non-complying den-tists.54 For example, the agreement requires CSHM’s board to ‘‘en-sure that each individual cared for by [CSHM] and in [CSHM] fa-cilities receives the professionally recognized standards of care.’’ 55 While the CIA provisions to ensure CSHM follows recognizedstandards of care are well-intentioned, it creates an affirmativeduty for CSHM to exercise control over the professional judgment
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56MIC Memorandum, FORBA, LLC, Arcapita at 26–27 (June 2006) (FORBA l 0046011) (Ex-hibit 10) (emphasis added). Arcapita was the private equity firm that owned FORBA, LLC.
57See FORBA, March Madness at 1 (FORBA 0236082/CSHM–00002086) (Exhibit 11).58See FORBA, The Road to the Super Bowl (FORBA 0230059/CSHM–00002004) (Exhibit 45).
of dentists in states that do not allow a corporation to own dentalclinics or interfere with dentists’ professional judgment. Therefore,the CIA has the effect of enhancing control over dental clinic oper-ations by CSHM which is a corporation that is not licensed to prac-tice dentistry.
B. The Influence of Private Equity
Venture capital and private equity deals are central to economicgrowth and innovation. However, the interest of private equity tar-geting dental practices within the Medicaid system is alarming—especially considering the regular complaints of private dentistsand doctors about low Medicaid reimbursement rates. If a dentistin a small family practice cannot afford to take Medicaid patientsbecause of low reimbursement rates, why would private equity in-vest capital in this business model? What can firms backed by pri-
vate equity investment do to make money from Medicaid patientsthat locally owned and operated practices cannot or will not do?The answer is ‘‘volume.’’
Through various meetings—both with CSHM executives and em-ployees at the Small Smiles Oxon Hill facility—Committee staff were told that CSHM’s business model was to increase patient vol-ume as much as possible. In order to do this, CSHM executives andstaff claimed that due to the population the clinics are serving,they must over-book appointments. This means, at times, two tothree patients will be scheduled for a single time slot. CSHMclaims that Medicaid patients tend to be unreliable, often not show-ing up for scheduled appointments. This is confirmed by a 2006memorandum assessing FORBA’s (CSHM’s precursor) value:
Importantly, FORBA’s unique business model mitigates the33% broken appointment challenge in that patients are notscheduled to have appointments with specific dentists. Instead,any one of four dentists at a clinic can see a patient. Therefore,since FORBA employs a minimum of three to four dentists perclinic, FORBA can leverage its critical mass of dentists andover-schedule appointments by 25%.56
CSHM has also employed the use of bonuses as a way toincentivize their employees, both dentists and non-dentists, tomaximize volume and profit. Under FORBA’s leadership, employ-ees received both a salary and productivity-based bonuses based oncontests amongst dental clinics. Bonuses were based on: (1) dailyaverage productivity, (2) broken appointment rates, (3) number of patients seen per day, and (4) number of patients converted fromproviding simple hygiene to operative dental work (at a higher re-imbursement rate).57 Based on a clinic’s productivity level, employ-
ees could receive up to $1,000.58 FORBA would hold these contestsmultiple times throughout the year.
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59See CSHM/Small Smiles Dental Center of Holyoke, LLC, Lead Dentist Employment Agree-ment with Dr. [REDACTED] at 4–6 (Aug. 30, 2010) (Exhibit 12).
60 Id.61CSHM Exit Interview, Medrina Gilliam at 1 (July 1, 2011) (CSHM–00006826) (Exhibit 13).62See E-mail chain from Dr. [REDACTED] to Dr. [REDACTED] (May 19–20, 2011) (Exhibit
9).63 Id.64 Id.65Letter from Dep’t Health and Human Services, OIG, to Senators Baucus and Grassley, re:
Corporate Integrity Agreement with CSHM, w/attach. at 2 (Oct. 4, 2012) (Exhibit 14).66CSHM/FORBA Holdings, LLC, State Settlement Agreement with the State of N.Y. (Jan. 20,
2010) (Exhibit 15).67See Civil Settlement Agreement, FORBA and Dep’t of Justice (Jan. 15, 2010) (Exhibit 2).68See id.69See Letter from Dep’t Health and Human Services, OIG, to Senators Baucus and Grassley,
re: Corporate Integrity Agreement with CSHM, w/attach. at 2 (Oct. 4, 2012) (Exhibit 14).
Under management by CSHM, compensation is based on the rev-enue of that dental clinic as well as the collections of each den-tist.59 This productivity-based compensation arrangement priori-tizes volume, operative procedures over preventive care, and en-courages unnecessary care.60 In fact, when asked what aspects of her job were the most dissatisfying in an exit interview withCSHM, one Lead Dentist disclosed, ‘‘Only after doctors were con-verted to production[-]based compensation. This conversion causeddistractions and realignment of priorities. Inability to concentrateonly on dentistry and patient needs.’’ 61 [sic]
If dentists in a CSHM clinic feel the schedule is unmanageable,they are not permitted to hire additional employees to handle theincreased workload without approval from CSHM executives. Nordo they have the authority to reduce their own patient load. Forexample, in a May 2011 e-mail from a Lead Dentist to CSHM man-agement, the Lead Dentist complained to CSHM management that
staffing was not at the appropriate level to handle the patient loadthey were carrying.62 CSHM replied that, ‘‘As we discussed yester-day, the patient load will not be reduced without collaboration fromCSHM.’’63 The Lead Dentist replied, ‘‘I will not be [held] respon-sible for errors in my center when we have asked for help numer-ous times.’’ 64
C. Federal Government Intervention
In 2010, after a lengthy investigation into the company by theUnited States Department of Justice, CSHM entered into a CIA with the United States Department of Health and Human Serv-ices,65 as well as settlement agreements with the United States De-partment of Justice and 22 states.66 The Department of Justice set-tlement cites conduct by FORBA (now CSHM) from the time periodof September 2006 through June 2010.67 Specifically, the conduct
noted in the agreement includes submitting Medicaid reimburse-ment claims for medically unnecessary pulpotomies, crowns, extrac-tions, fillings, sealants, x-rays, anesthesia, and behavior manage-ment; failing to meet professionally recognized standards of care;and provision of care by unlicensed persons.68 CSHM’s CIA withthe Department of Health and Human Services required CSHM toinstitute rigorous compliance procedures and programs, as well assubmit to regular audits and reviews by an Independent Monitor.69
To date, the Independent Monitor has audited and reviewed 60Small Smiles clinics through an onsite review or desk audit since2010. Consistently, the Independent Monitor reports reveal that
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70See Independent Monitor Report, Oxon Hill, Md. at 11 (Apr. 20, 2012) (Exhibit 16).71See Independent Monitor Report, Worcester, Mass. at 5 (Jan. 4, 2011) (Exhibit 46); Inde-
pendent Monitor Report, Thornton, Colo. at 6 (Feb. 4, 2011) (Exhibit 47); Independent MonitorReport, Santa Fe, N.M. at 6 (Mar. 7, 2011) (Exhibit 48); Independent Monitor Report, Albu-querque, N.M. at 5 (Apr. 8 2011) (Exhibit 49); Independent Monitor Report, Myrtle Beach, S.C.at 6 (May 9, 2011) (Exhibit 50); Independent Monitor Report, Augusta, Ga. at 6 (July 1, 2011)(Exhibit 51); Independent Monitor Report, Austin, Tex. at 6 (July 29, 2011) (Exhibit 52); Inde-pendent Monitor Report, Mattapan, Mass. at 6 (Sept. 6, 2011) (Exhibit 53); Independent Monitor
Report, Manassas, Va. at 8 (Sept. 22, 2011) (Exhibit 23); Independent Monitor Report, Youngs-town, Ohio at 5 (Oct. 14, 2011) (Exhibit 27); Independent Monitor Report, Oklahoma City, Okla.at 6 (Nov. 4, 2011) (Exhibit 54); Independent Monitor Report, Mishawaka, Ind. at 6 (Oct. 5,2012) (Exhibit 40); Independent Monitor Report, Brockton, Mass. at 6 (Nov. 9, 2012) (Exhibit55); Independent Monitor Report, Denver, Colo. at 7 (Dec. 7, 2012) (Exhibit 56). The 44% figurewas calculated by averaging the CSHM score and the Independent Monitor score for each doctorin the listed reports. The difference was found between each score, which resulted in 44% higheraverage in CSHM scores than Independent Monitor scores.
72 Id. at 8.73See Small Smiles Clinic, Oxon Hill, Md. Photograph of signs (Exhibit 37).
clinic employees had little awareness of the new compliance proce-dures, and that CSHM was giving its dentists passing grades onchart audits which the Independent Monitor says they clearlyfailed.70 In fact, of the 14 reports that graded the clinic doctors ona 100-point scale, CSHM gave their doctors grades that were on av-erage 44% higher than the grade that the Independent Monitorawarded.71
D. Committee Staff Site Visit to Small Smiles of Oxon Hill,Maryland
On March 7, 2012, Committee staff arranged a site visit at aSmall Smiles Dental Center in Oxon Hill, Maryland, during anaudit by the Independent Monitor.72 The center was large, reason-ably well kept, and clinic employees were friendly and welcoming.Signs informing parents of their right to join their children in the
treatment area were prominently displayed in both English andSpanish: 73
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74See generally Interview with Marty Reyes, CDA, EFDA, Office Manager and Compliance Li-aison of Small Smiles Clinic Oxon Hill, Md. (Mar. 7, 2012).
75
See CSHM Office Manager’s Manual, v. 06–2011, at 15 (Dec. 17, 2010) (Exhibit 17).76See Interview with Marty Reyes, CDA, EFDA, Office Manager and Compliance Liaison of Small Smiles Clinic Oxon Hill, Md. (Mar. 7, 2012).
77See Daily Patient Flow at 5 (Apr. 13, 2011) (Exhibit 18).78 Interview with Marty Reyes, CDA, EFDA, Office Manager and Compliance Liaison of Small
Smiles Clinic Oxon Hill, Md. (Mar. 7, 2012); see discussion at Parts E.2.79 Id.80 Id.8134 A M. A CAD. OF PEDIATRIC DENTISTRY , REFERENCE M ANUAL: GUIDELINE ON BEHAVIOR
GUIDANCE FOR THE PEDIATRIC DENTAL P ATIENT 176 (1990) (emphasis added) (Exhibit 19).82 Id.
Committee staff was given the opportunity to sit in with theIndependent Monitor during the interview of three employees of the clinic and ask supplemental questions.
The first employee interviewed was the clinic’s Office Manager/ Compliance Liaison.74 The role of the Compliance Liaison is tokeep up-to-date with CSHM compliance policies and ensure thatstaff is knowledgeable and well-trained in compliance policies.75 For example, the Compliance Liaison is responsible for regularlychecking the company’s web portal to see if there are any new com-pliance trainings on topics such as X-ray safety, record manage-ment, and billing practices.76 During questioning, it became in-creasingly clear that the Compliance Liaison was simply too busyrunning the clinic to keep up with his compliance duties. This par-ticular clinic treats as many as 70 children each day, and makesappointments for well over 100.77
The Compliance Liaison also indicated that he was previously
the Office Manager and Compliance Liaison at yet another troubledSmall Smiles clinic in Manassas, Virginia.78 When asked whetherhe thought there were any problem areas with the Manassas clinic,he responded that he did not think so.79
The next employee interviewed was the Clinical Coordinator. TheClinical Coordinator is typically a facilitator—making certain thatthe busy treatment area operates efficiently. The Clinical Coordi-nator maintains and orders supplies, monitors patient flow, andkeeps things moving. During the interview, it was clear that theClinical Coordinator was not knowledgeable about important safetyand compliance policies. For example, when the Independent Mon-itor asked what should be done when a child has evidence of toothdecay, but will not sit still for X-rays, the Clinical Coordinator re-sponded that the dental assistant or available staff should sit withthe child in the X-ray area and hold the child still.80 However, pe-
diatric dental education literature emphasizes that given ‘‘associ-ated risks and possible consequences of [protective stabilization],the dentist is encouraged to evaluate thoroughly its use on each pa-tient and possible alternatives.’’ 81 A dentist must consider the fol-lowing factors prior to using protective stabilization: ‘‘1. alternativebehavior guidance modalities; 2. dental needs of the patient; 3. theeffect on the quality of dental care; 4. the patient’s emotional devel-opment; [and] 5. the patient’s medical and physical consider-ations.’’ 82 The Clinical Coordinator was terminated.
Finally, Committee staff questioned the ‘‘owner dentist’’ of OxonHill Small Smiles, who was also the Lead Dentist. The ‘‘owner den-tist’’ appeared nervous when speaking with the Independent Mon-itor and Committee staff, but appeared genuinely passionate about
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83 Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles Clinic OxonHill, Md. (Mar. 7, 2012).
84 Id.85 Id.86See discussion at Parts E.2.87 Id.88 Interview with Gillian Robinson-Warner, DDS, Lead Dentist of Small Smiles Clinic Oxon
Hill, Md. (Mar. 7, 2012).89 Id.90 Id.91 Id.92 Id.
dental care for underprivileged children. When asked about the de-tails of her compensation, the ‘‘owner dentist’’ stated that she re-ceives a salary, and an additional flat payment for being the‘‘owner dentist.’’ 83 When asked how many Small Smiles DentalCenters she owned, she stated that she owned five clinics and had
just recently become the owner of the Manassas, Virginia clinic.84 She was then asked if she received an additional flat fee paymentfor each clinic that she owned, and she stated that she did not.85 Following up on that question, she was asked why she chose to be-come the owner of the troubled Manassas 86 clinic for no additionalcompensation, and she stated that she was told it would have toclose if she did not agree to become the owner.87 The ‘‘owner den-tist’’ was then asked if she could name any of the dentists underher employ at the Manassas clinic she purported to own.88 Shecould not name a single dentist at that facility. When asked if she
had ever been to the Small Smiles clinic in Manassas, she repliedthat she had not.89 When asked whether she knew the names of any of the dentists at another Maryland clinic she purported toown, she struggled for some time before recalling one dentist’s firstname.90
The next line of questioning for the ‘‘owner dentist’’ was regard-ing her control over operations at the clinics she supposedly owns.She was adamant that all medical decisions remain under her con-trol. However, she conceded that CSHM receives 100% of the pro-ceeds of the business, pays all of the staff salaries at her clinic,pays her salary, dictates the number of patients to be scheduled foreach day, sets the budget for supplies, rents the space the clinicuses, and has complete control over all hiring and firing deci-sions.91 When pressed further regarding her ability to hire addi-tional staff should the clinic need an additional dentist to keep up
with demand and provide quality care, she did not wish to engagein the hypothetical discussion, but conceded that she had neverhired or fired anyone without the permission of CSHM.92
Despite the language in the management services agreement re-garding the payment structure and management fees paid toCSHM, it is clear that the ‘‘owner dentists’’ have no idea where themoney from the procedures for which they bill Medicaid actuallyends up. ‘‘Owner dentists’’ are merely paid a salary by CSHM andreceive a flat fee to assert ownership to their respective state, butthey exercise none of the traditional elements of ownership.
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93See IMR Oxon Hill, Md. at 27 (Exhibit 16).94 Independent Monitor Report Phoenix, Ariz. at 3 (Dec. 23, 2010) (Exhibit 20).95NuSmile, Pediatric Crowns, http://www.nusmilecrowns.com (last visited Mar. 22, 2013).96 IMR Phoenix, Ariz. at 3 (Exhibit 20).97Thikkurissy, Sarat, et al., Pulpotomy to Stainless Steel Crown Ratio in Children With Early
Childhood Caries: A Cross-sectional Analysis Pediatric Dentistry, Pediatric Dentistry, vol. 33 n.7, 496, (Nov./Dec. 2011) (Exhibit 21).
98 Arizona Health Care Cost Containment System—Schedule of Dental Rates (Jan. 1, 2007)(Exhibit 22). Each pulpotomy costs $81. Id. at 2.
E. CSHM Repeatedly Fails to Meet Quality and ComplianceStandards
The Department of Health and Human Services Office of Inspec-tor General and the Independent Monitor have closely monitoredSmall Smiles clinics and their corporate owners since 2010. Moni-toring has included audits, site visits, fines, penalties, and changesto management, and yet CSHM repeatedly fails to meet basic qual-ity and compliance standards. According to Independent Monitorreports, the company is still rushing through dental treatments,providing substandard and in some cases dangerous care, per-forming medically unnecessary treatments, and risking the safetyof children—all of which are ultimately financed by taxpayersthrough the Medicaid program.93
Each time the company fails to meet its obligations or the Inde-pendent Monitor uncovers problems, the company promises to do
better, and HHS OIG gives CSHM another chance. The following sections outline the major failures of CSHM during the monitoring period, and the seemingly endless capacity for the government togrant the company more chances.
1. Phoenix, Arizona Independent Monitor Report
The Independent Monitor visited a Small Smiles clinic in Phoe-nix, Arizona on December 23, 2010, relatively early on in the moni-toring period. At this clinic, the Lead Dentist informed the Inde-pendent Monitor that she automatically performed pulpotomies onprimary anterior teeth that received a NuSmiles crown.94 A NuSmiles crown is a stainless steel crown (SSC) with a natural-looking, tooth-colored coating.95 According to the Lead Dentist, ‘‘theamount of tooth structure removal necessary to prepare the teethfor the crowns endanger the pulp and necessitated pulpotomies.’’ 96 However, a pulpotomy is only necessary when the nerve is exposed,and is typically only indicated in one-third of patients.97 Therefore,if the patient population is typical, two-thirds of the pulpotomiesthat the Lead Dentist in Phoenix performed were potentially un-necessary, at a total cost of approximately $5,300 per 100 Medicaidpatients.98 Not only is this a quality of care issue, with children re-ceiving unnecessarily prolonged treatments, but it is also a drainon the Medicaid system. When dentists perform unnecessarypulpotomies, it is the Medicaid system that initially foots the bill,and then ultimately the taxpayers. It is unclear whether outside in-fluence or information compelled the dentist to do pulpotomiesevery single time, but this case illustrates that the trainings andcompliance programs necessitated by the CIA were largely ineffec-tual.
Of the 30 records reviewed by the Independent Monitor, 15 docu-mented children being strapped down to a papoose board during
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99 IMR Phoenix, Ariz. at 17 (Exhibit 20).100 Id. at 18.101 Id. at 17.102 Id. at 17–18.103 Independent Monitor Report Manassas, Va. at 2 (Sept. 22, 2011) (Exhibit 23).104 Independent Monitor Report, Worcester, Mass. at 5 (Jan. 4, 2011) (Exhibit 46); Inde-
pendent Monitor Report, Thornton, Colo. at 6 (Feb. 4, 2011) (Exhibit 47); Independent MonitorReport, Santa Fe, N.M. at 6 (Mar. 7, 2011) (Exhibit 48); Independent Monitor Report, Albu-
querque, N.M. at 5 (Apr. 8 2011) (Exhibit 49); Independent Monitor Report, Myrtle Beach, S.C.at 6 (May 9, 2011) (Exhibit 50); Independent Monitor Report, Augusta, Ga. at 6 (July 1, 2011)(Exhibit 51); Independent Monitor Report, Mattapan, Mass. at 6 (Sept. 6, 2011) (Exhibit 53);Independent Monitor Report, Manassas, Va. at 8 (Sept. 22, 2011) (Exhibit 23); IndependentMonitor Report, Youngstown, Ohio at 5 (Oct. 14, 2011) (Exhibit 27); Independent Monitor Re-port, Oklahoma City, Okla. at 6 (Nov. 4, 2011) (Exhibit 54); Independent Monitor Report,Mishawaka, Ind. at 6 (Oct. 5, 2012) (Exhibit 40); Independent Monitor Report, Denver, Colo.at 7 (Dec. 7, 2012) (Exhibit 56).
105CSHM Policy on Protective Stabilization at 3 (Jan. 14, 2012) (Exhibit 24).106Guideline on Behavior Guidance for the Pediatric Dental Patient, American Academy of Pe-
diatric Dentistry, vol. 33 no. 6, 167–68 (2011/2012) (Exhibit 25).
treatment.99
However, none of these patients received nitrousoxide/oxygen anesthesia, which is the preferred method of calming young dental patients.100 Furthermore, one child was documentedas being on the papoose board for 1 hour and 45 minutes, withoutmonitoring of vital signs or a bathroom break.101 This is a clearviolation of CSHM’s policies and is dangerous and distressing forthe child.102
This early Independent Monitor report demonstrates that manyof the problems identified in prior news reports and flagged by DOJin 2007 and 2008 were still common practice at Small Smiles inlate 2010, including unnecessary procedures, overuse of the pa-poose board on distressed children, and a general lack of under-standing by Small Smiles dentists regarding how children shouldbe treated.
2. Manassas, Virginia Independent Monitor Report
The Independent Monitor visited a Small Smiles clinic in Manas-sas, Virginia on September 22, 2011—nearly one year after the ini-tiation of compliance programs, training, and monitoring by thegovernment. The Independent Monitor found many of the sameproblems, and nearly an identical case involving the misuse of apapoose board. Both dentists at the clinic scored lower on the Inde-pendent Monitor’s evaluation than on a previous internal auditconducted by CSHM. These dentists did not follow proper protocolsfor implementing and documenting dental procedures, and this ul-timately resulted in one dentist receiving an automatic failure fromthe Independent Monitor.103 This fact is critical. The purpose of themonitoring period is that, at the end of 5 years, CSHM should beable to use its own internal monitoring and compliance programs.In numerous Independent Monitor reports, however, CSHM’s au-dits have given dentists passing grades, while the subsequent Inde-
pendent Monitor’s review found that these same dentists clearlyfailed.104 Therefore, despite the passage of time and ample guid-ance from the government, CSHM is still unable to rely on its owninternal monitoring and compliance programs.
Just like the Phoenix clinic, one dentist at the Manassas clinicutilized a papoose board on a patient for 1 hour and 45 minutes,a violation of CSHM use of restraint policy,105 and in violation of generally recognized standards from the American Academy of Pe-diatric Dentists.106
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107See IMR Manassas, Va. at 2 (Exhibit 23).108 Id.109 Id. at 3.110 Virginia Smiles for Children—Schedule of Allowable Fees (Exhibit 66). Each pulpotomy
costs $80.69.111 Id.
Another example includes one dentist automatically failing dueto the lack of documentation for medical necessity.107 Manassasclinic dentists billed Medicaid for reimbursement of X-rays eventhough the Independent Monitor’s audit found no evidence that the
X-rays were actually performed.108 Five records revealed patientsreceiving treatment for 8 to 12 teeth during a single visit withoutthe proper amount of anesthesia being administered. Of 244pulpotomies performed, 104 ‘‘were not medically necessary,’’ 109 costing taxpayers and the Medicaid program a total of $8,391.110 This audit also revealed that CSHM’s chart audit tool failed to un-cover several documentation errors and improper anesthesiause.111
Allegations of abuse plagued the Manassas clinic, leading to itseventual closure by CSHM. The Committee staff have received in-formation that the Virginia Department of Health Professions will
be reviewing the dentists who practiced at the Manassas clinic.Contrary to assertions that a vulnerable population would go un-
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112See Interview with Church Street Health Management, in Washington, D.C. (Feb. 21,2012).
113See IMR Oxon Hill, Md. at 27 (Exhibit 16).114 Id. at 36.115 Id.116 Id.117See id. at 27.118 Id. at 36 (emphasis added).
treated without Small Smiles, the patients of the Manassas clinicand other clinics closed by CSHM have been absorbed into otherpractices with little difficulty.112
3. Oxon Hill, Maryland Small Smiles Clinic
The report issued by the Independent Monitor after the site visitat the Oxon Hill Small Smiles confirms the findings of the Com-mittee staff who observed the clinic with the Independent Monitor.
First, the Independent Monitor discovered numerous quality of care issues. It found that the clinic was inappropriately docu-menting and administering local anesthetics and nitrous oxide.113 Notably, the Independent Monitor observed that ‘‘[t]he maximumdose of local anesthetic was not calculated for patients treated bythe Lead Dentist before she administered local anesthetic.’’ 114 Rather, local anesthetic calculations were performed and filled inafter the fact.115 Moreover, the clinic was found to be substituting
the papoose board for anesthesia or nitrous oxide.116 This meansthat the child was both experiencing pain while also being re-strained. Out of 30 records, there were six instances in which achild younger than 5 years old was restrained during treatmentwithout the use of local anesthetic, and seven instances in whichprimary teeth fillings on children younger than 7 years old wereadministered without local anesthesia or nitrous oxide.117
Second, the Independent Monitor found alarming practices thathad threatened patient safety at Oxon Hill, Maryland clinic. Onenotable incident involved a child treated with a pulpotomy and astainless steel crown who was restrained using a patient stabiliza-tion device (PSD):
[C]hild screamed and fought the entire time. The patient keptmoving her head, making it difficult to keep it secured. Shevomited approximately half way through the procedure. Thedentist immediately turned the patient on her side andsuctioned her mouth and throat. This child’s airway was in
jeopardy because the mouth prop opened her mouth so wide itrestricted her ability to swallow and protect her airway. Thepatient was screaming and gasping, leaving her airway openand vulnerable. Cotton pellets used during the pulpotomy wereplaced and removed while SSC’s were fitted and removed on amoving, combative, and hysterical child with no methods em-ployed to protect the airway.118
Notably, the dentist resumed treatment despite the child’s vom-iting.
Most shocking was the Independent Monitor’s final observationregarding the clinic:
Treatment was provided to restrained children who were fight-
ing, crying, and basically hysterical, using large mouth props
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119 Id. at 5.120 Id. at 29.121See Letter from CSHM to HHS OIG, re: Reporting of Substantial Overpayment to Small
Smiles Dental Centers of Oxon Hill at 2 (May 22, 2012) (Exhibit 57).122See id.123Letter from HHS OIG to CSHM, re: Demand for Stipulated Penalties and Notice of Mate-
rial Breach and Intent to Exclude (June 22, 2012) (Exhibit 26).124 Id. at 4–5.
that overextended their mouths, compromising their ability toswallow and protect their airways. Water spray from handpieces, cotton pellets used for pulpotomies, and stainless steelcrowns (SSCs) that are fitted and removed all presented poten-tial risk to these children’s airways.
Preparedness and anticipation was lacking on the part of thedental assistants during procedures on uncooperative young children.119
Third, the Independent Monitor found instances in which nomedical necessity was provided for treatments performed. In 9 of the 30 records reviewed by the Independent Monitor, no docu-mentation or X-rays were provided to support the medical necessityof treatments provided to patients.120 Therefore, in 30% of therecords reviewed, the Medicaid program was billed for unjustifiedand potentially unnecessary treatments. Larger sampling at thisand other clinics could reveal massive overpayments by the govern-ment to CSHM.
4. Oxon Hill, Maryland Small Smiles Overpayment
At the Oxon Hill Small Smiles Center, mentioned above, HHSOIG was alerted to an $852,492.74 overpayment.121 Not only wasthis clinic providing substandard care, according to the Inde-pendent Monitor, it was also providing unnecessary treatments andgetting excessive payments from Medicaid. Shortly after the over-payment was identified, CSHM satisfied its obligations under theCIA to refund the overpayment.122
5. Youngstown, Ohio Clinic
Similar problems occurred at the Youngstown, Ohio clinic, where
the Independent Monitor found that the clinic provided unneces-sary care and also had billing, reimbursement, and records man-agement issues. HHS OIG even went as far as to demand thatSmall Smiles pay a $100,000 stipulated penalty and issued a No-tice of Material Breach and Intent to Exclude to the Youngstownclinic. Such notices signal that HHS OIG intends to exclude a facil-ity from the Medicaid program. Exclusion would prohibit a facilityfrom treating Medicaid beneficiaries and seeking state and Federalreimbursement. HHS OIG cites the Independent Monitor reportfindings as the primary reason to exclude the Youngstown facilityfrom participating in the Medicaid program.123
Specifically, 7 of the 15 records reviewed by the IndependentMonitor revealed a lack of documentation or radiographic evidenceto support medical necessity for treatments provided by SmallSmiles.124 Of those 7 records, 6 revealed pulpotomies were per-
formed without medical necessity, while one record showed no X-
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125 Id.126 Id. at 5.127 Independent Monitor Report Youngstown, Ohio at 11 (May 25, 2012) (Exhibit 27) (empha-
sis added).128See Letter from HHS OIG, to CSHM, re: Resolution of the Stipulated Penalties and Notice
of Material Breach and Intent to Exclude Matter at 2 (Aug. 23, 2012) (Exhibit 28).129 Id. at 1.130See id.131Letter from HHS OIG to CSHM, re: Notice of Material Breach and Intent to Exclude at
1 (Mar. 8, 2012) (Exhibit 29).
rays or photographs were taken to support the medical necessityfor treatment provided.’’ 125 The Independent Monitor report found ‘‘poorly performed fillings
and stainless steel crowns, undiagnosed recurrent decay or faultyrestorations, lack of rationale for extractions, no use of local anes-thesia for placement of fillings in teeth with deep decay, use of multiple surface fillings without any substantiation as to whystainless steel crowns were not used.’’ 126 In perhaps the most trou-bling violation observed by the Independent Monitor, the report de-scribes:
A combative 4-year-old child received a cut to the tongue whilethree teeth were being treated with fillings, a pulpotomy anda [stainless steel crown]. The documentation in the patient’srecord did not record the size of the cut and reported the pa-tient was ‘‘very strong and vocal.’’ Four people were required
to help manage the patient. Documentation also showed thata protective stabilization device (PSD) was used and the pa-tient was ‘‘double wrapped’’ in order to provide treatment. Thee-mail communication related with this case did not show that
X-rays were requested; therefore, it appeared there was noevaluation to determine whether the treatment ren-dered was medically necessary.127
On July 3, 2012, HHS OIG received confirmation that CSHMpaid the $100,000 stipulated penalty.128 On August 23, 2012, HHSOIG sent a letter to CSHM stating that it determined that CSHM‘‘cured the breaches identified in the OIG’s Notice, and will not pro-ceed with an exclusion action against CSHM’s Small Smiles DentalCenters of Youngstown at this time.’’ 129 CSHM advised HHS OIGof its effort to cure the specific breaches through various actions,including: (1) evaluation and termination of nine staff people;
(2) the temporary, 2-day closure to conduct training; and (3) the de-velopment of an ongoing oversight and monitoring plan by theChief Compliance Officer, Chief Dental Officer, the Regional Direc-tor, and the Senior Vice President of Operations.130
F. Health and Human Services Office of Inspector GeneralNotice of Intent to Exclude
On March 8, 2012, HHS OIG sent a Notice of Material Breachand Intent to Exclude to CSHM. HHS OIG states in its letter thatdue to CSHM’s ‘‘repeated and flagrant violation of certain provi-sions’’ of the CIA, the OIG is exercising ‘‘its right under the CIA to exclude CSHM from participation in the Federal health care pro-grams.’’ 131 HHS OIG largely cites violations occurring at the Ma-nassas, Virginia clinic as primary reasons for its intent to exclude.Specifically, HHS OIG points to five main areas in which CSHM
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132 Id. at 2–8.133 Id. at 2.134 Id. at 3.135 Id.136See Letter from HHS OIG to CSHM, re: Notice of Material Breach and Intent to Exclude
at 3 (Mar. 8, 2012) (Exhibit 29).137Letter from HHS OIG, to CSHM, re: Notice of Material Breach and Intent to Exclude at
2–3 (Mar. 13, 2012) (Exhibit 30).138 Id.139 Id. at 6 (emphasis added).
violated the terms of the CIA: (1) management certifications andaccountability; (2) policies and procedures requirements; (3) changeto termination policy and procedure; (4) CSHM review of pulp-to-crown ratios and provision of medically unnecessary services atother CSHM facilities; and (5) quality of care reportable event re-quirements.132
Part of complying with the CIA requires CSHM to certify thateach employee knows and understands his/her responsibilities andduties under Federal law, state dental board requirements, andprofessionally recognized standards of care. The certification alsorequires the employee to ‘‘attest that his/her job responsibilities in-clude ensuring compliance with regard to the area under his/hersupervision. . . .’’ 133 On March 15, 2011, CSHM submitted a reportto the HHS OIG, including a certification for LaTanya O’Neal, theLead Dentist in the Manassas, Virginia clinic. On November 16,2011, HHS OIG conducted a site visit to the Manassas Clinic togauge if the clinic was in compliance with its obligations under theCIA. During this site visit, the OIG interviewed Ms. O’Neal to as-certain her level of compliance and discuss her oversight role asLead Dentist. Unfortunately, Ms. O’Neal was not able to address‘‘any compliance-related obligations that she oversaw at ManassasCenter.’’ 134 Additionally, Ms. O’Neal could not ‘‘recall signing anannual certification or any specific steps that she took to evaluatecompliance at Manassas Center for purposes of signing that certifi-cation.’’ 135 Ultimately, HHS OIG found Ms. O’Neal’s certification tobe false.136 CSHM responded that it could not cure the breach of having submitted a false certification, but indicated that the Certi-fying Employee who signed the false certification is no longer em-ployed by CSHM. Additionally, CSHM ‘‘implemented significanttraining and revamped [its] process for certifications.’’ 137 Thesetwo actions were enough to satisfy HHS OIG.
Section III.B.2.u of the CIA requires CSHM to have written Poli-cies and Procedures in place to terminate employees who have beenfound to have violated professionally recognized standards of health care.138 In January 2012, CSHM revised its ‘‘AdverseEvents, Quality of Care Reportable Events, and OMIG PatientCare Matters’’ policy which states the following:
Practitioners who have violated professionally recognizedstandards of healthcare, including the AAPD Guidelines, theCSHM Clinical Policies and Guidelines for CSHM AssociatedDental Centers, and any applicable state or local standards orguidelines, and whose violation has been deemed by the Chief Dental Officer to be a Quality of Care reportable event will beterminated or will undergo a remediation plan developed by theChief Dental Officer with approval of the OIG.139
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140Letter from HHS OIG to CSHM, re: Notice of Material Breach and Intent to Exclude at6 (Mar. 8, 2012) (Exhibit 29).
141 Id.142
Id.143 Id. at 7.144 Id.145See id.146Letter from HHS OIG to CSHM, re: Notice of Material Breach and Intent to Exclude at
7 (Mar. 8, 2012) (Exhibit 29).147 Id. at 7–8.148Letter from CSHM, to HHS OIG, re: Notice of Material Breach and Intent to Exclude (Mar.
12, 2012) (Exhibit 64).149Letter from HHS OIG, to CSHM, re: Notice of Material Breach and Intent to Exclude (Mar.
13, 2012) (Exhibit 30).
The CIA does not allow for the Chief Dental Officer to dismantlethe termination process with a remediation plan. Therefore, HHSOIG found this revision to directly contradict the requirements of the CIA because it allowed the Chief Dental Officer to avoid thetermination requirement with his/her own remediation plan.140
Part of every audit conducted under the CIA includes a deskaudit report. Included in each desk audit is a review of all of thedental work associated with that clinic. The Manassas, Virginiaclinic desk audit report ‘‘indicated that of 244 pulpotomies reviewedby the Monitor, 104 were medically unnecessary.’’ 141 The deskaudit also found that as a result, CSHM improperly billed the Med-icaid program. CSHM issued a response to the findings on October31, 2011, stating that it ‘‘agrees that pulpotomies were performedthat were not medically necessary . . . [and that] CSHM’s systemswere ineffective in identifying this issue.’’ 142
Included in the October 2011 response, CSHM also identified 13
dentists with high pulp-to-crown ratios similar to those at the Ma-nassas Clinic in its response to the desk audit.143 CSHM was plan-ning on addressing these 13 dentists by ‘‘monitor[ing] the pulp-to-crown ratio for each of these 13 individuals’’ and providing ‘‘indi-rect pulp therapy as an alternative to pulpotomies.’’ 144 After itsOctober 2011 response, CSHM clarified that it had identified 12dentists, and not 13 dentists, who exhibited high pulp-to-crown ra-tios.145 However, HHS OIG was not able to determine whetherCSHM ‘‘had performed or planned to perform a financial review of claims it submitted on behalf of the 12 identified dentists to deter-mine whether CSHM had any overpayment or other liability forclaims that were associated with high pulp-to-crown utilization.’’ 146 HHS OIG determined this was a breach of CSHM’s duty to developand implement a policy to promptly and appropriately investigatecompliance issues.147
CSHM had 30 days to demonstrate to HHS OIG that its materialbreach had been cured. CSHM submitted a written response onMarch 12, 2012, and met with HHS OIG on March 13, 2012.148 Later that day, on March 13, 2012, HHS OIG sent CSHM a letterformalizing the terms of the agreement with CSHM whereby theOIG would not proceed with an exclusion action for the CIA breaches identified in the March 8, 2012 notice.149
With respect to the Manassas facility, HHS OIG agreed not topursue an exclusion action that would apply to the entire companyif CSHM agreed to: (1) a voluntary exclusion of Manassas Centerwithin 90 days of the date of March 13, 2012, letter; and (2) complywith additional program integrity-related obligations that will be
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150 Id. at 3.151E-mail chain between Committee Staff and HHS OIG re: Reporting Substantial Overpay-
ments to Small Smiles Dental Centers of Oxon Hill (Mar. 7, 2013) (Exhibit 59).152Letter from HHS OIG, to CSHM, re: Notice of Material Breach and Intent to Exclude at
4 (Mar. 13, 2012) (Exhibit 30).153E-mail chain between Committee Staff and HHS OIG re: Reporting Substantial Overpay-
ments to Small Smiles Dental Centers of Oxon Hill (Mar. 7, 2013) (Exhibit 59).154Letter from HHS OIG, to CSHM, re: Notice of Material Breach and Intent to Exclude at
4 (Mar. 13, 2012) (Exhibit 30).155E-mail chain between Committee Staff and HHS OIG re: Reporting Substantial Overpay-
ments to Small Smiles Dental Centers of Oxon Hill (Mar. 7, 2013) (Exhibit 59).156Letter to CSHM, from HHS OIG, re: Notice of Material Breach and Intent to Exclude at
4–5 (Mar. 13, 2012) (Exhibit 30).
incorporated as an amendment to the CIA by the March 13, 2012letter. On June 4, 2012, CSHM sold the Manassas Clinic to a thirdparty buyer, satisfying the first requirement.
The additional integrity-related provisions HHS OIG placed onCSHM include the following:
1. Compliance Program Onsite Reviews of CSHM Facilities.‘‘Within 30 days CSHM shall develop and implement a processby which the Chief Dental Officer, the Compliance Officer, andRegional Dentists shall conduct at least one onsite review eachmonth to a CSHM facility for the purpose of evaluating and en-suring compliance with all Federal health care program re-quirements, state dental board requirements, and the obliga-tions of the CIA. The OIG will require CSHM to recruit Re-gional Pediatric Dentists who will assist with the Onsite Re-views. . . .’’ 150
CSHM has completed its hiring of Regional Pediatric Den-tists.151
2. Quality Improvements Initiatives. ‘‘Within 30 days, CSHMshall develop and implement a process by which CSHM identi-fies specific risk areas and relevant quality benchmarks, taking into account the recommendations of the Independent Monitor.. . .’’ 152
CSHM fulfilled this requirement within the allocated timeframe set forth by the HHS OIG.153
3. Referral Process. ‘‘Within 30 days, CSHM shall develop andimplement guidance for each CSHM facility regarding patientreferrals from CSHM facilities to other facilities betterequipped to treat a patient in specific circumstances involving
concerns for patient safety, including but not limited to anes-thesia requirement[s] and behavior guidance techniques.’’ 154
CSHM fulfilled this requirement within the allocated timeframe set forth by the HHS OIG.155
4. Certifying Employee Certifications. ‘‘Within 30 days, CSHMshall develop a process by which Certifying Employees shallperform a comprehensive assessment of the areas of his/her re-sponsibility under Federal law, state dental board require-ments, and the obligations under the CIA.’’ 156
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157E-mail chain between Committee Staff and HHS OIG re: Reporting Substantial Overpay-ments to Small Smiles Dental Centers of Oxon Hill (Mar. 7, 2013) (Exhibit 59).
158Letter from HHS OIG, to CSHM, re: Notice of Material Breach and Intent to Exclude at5 (Mar. 13, 2012) (Exhibit 30).
159E-mail from Hinkle of HHS OIG, to CSHM from re: Reporting of Substantial Overpaymentto Small Smiles Dental Centers of Oxon Hill (Mar. 7, 2013, 11:22 a.m.) (Exhibit 58).
160Letter from Dep’t Health and Human Services, OIG, to Senators Baucus and Grassley, re:Corporate Integrity Agreement with CSHM, w/attach. at 5 (Oct. 4, 2012) (Exhibit 14).
161See Letter from Theodore Hester, Attorney at King & Spalding, to Senators Baucus andGrassley, at 1–2 (Nov. 29, 2011) (Exhibit 5).
CSHM fulfilled this requirement within the allocated timeframe set forth by the HHS OIG.157
5. Pulp-to-Crown Medical Necessity Review. ‘‘Within 120 days,CSHM shall review claims by those dentists with high ‘pulp-to-crown ratios’ to determine whether such documentation sup-ports the medical necessity of the services.’’
The Independent Monitor will give CSHM the appropriatepulp-to-crown ratio and CSHM will compare all dentists to thatstandard.158 HHS OIG has directed CSHM to conduct a newand more expansive review of the pulp-to-crown Medical Ne-cessity Review requirement, due in part to the change in own-ership in 2012.159
During the course of the breach, CSHM emerged from bank-ruptcy in June 2012 and began operating under a new owner, a
new Board of Directors, and a new senior management team. Thenew senior management team consists of a new Chief Executive Of-ficer, Chief Compliance Officer, Chief Dental Officer, and new Gen-eral Counsel. HHS OIG has stated that ‘‘The [Independent] Mon-itor has further indicated to OIG that the onsite visits to CSHM’sfacilities under the new ownership structure have all been posi-tive.’’ 160
G. Continuation of Abuses Following the Health and HumanServices Office of Inspector General Notice of Intent toExclude and New Ownership
The new owners have only been in place a relatively short time,but the issues involving quality of care and abuse of taxpayer dol-lars still remain. Time and time again, CSHM has demonstratedthat its Small Smiles clinics do not operate in compliance with the
CIA. The core of the problem appears to be structural. The newCSHM ownership acquired and has maintained their predecessors’flawed management services agreements, which remove traditionalownership authority from dentists. These agreements fundamen-tally limit the ability of the dentists to exercise independent clin-ical judgment.161 Despite management changes and assurancesthat the company is improving, the same problems that were un-covered in 2008 and ultimately led to the CIA persist. It is unac-ceptable that this type of activity has been allowed to continue for4 years despite aggressive oversight by the Independent Monitorand HHS OIG.
As stated above, in October 2012 HHS OIG declared that ‘‘TheMonitor has further indicated to OIG that the onsite visits toCSHM’s facilities under the new ownership have all been posi-
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162Letter from Dep’t Health and Human Services, OIG, to Senators Baucus and Grassley, re:Corporate Integrity Agreement with CSHM, w/attach. at 5 (Oct. 4, 2012) (Exhibit 14).
163 Independent Monitor Report Florence, S.C. at 2–3 (July 3, 2012) (Exhibit 38).164 Id.165See id. at 3.166See id.167See id.
tive.’’162
However, a review of Independent Monitor Reports fol-lowing the establishment of new CSHM ownership in June 2012and the subsequent Notice of Intent to Exclude, paints a very dif-ferent picture—the abuses that plagued Small Smiles clinics haveyet to subside. Although documenting different locations, the Inde-pendent Monitor’s reviews of CSHM clinics under new ownershipfrom late 2012 reveal findings of the same violations that plaguedthe Oxon Hill, Manassas, and other aforementioned clinics. Curi-ously, despite having previously received numerous IndependentMonitor reports of misconduct at CSHM facilities, in October 2012HHS OIG nonetheless proceeded to relay and seemingly endorse aninaccurate Monitor assertion that new CSHM ownership had begunto implement changes. Below are a few examples of the glaring er-rors that HHS OIG considers positive.
1. Florence, South Carolina Independent Monitor Report
In 2011, the Independent Monitor conducted a desk audit of theFlorence, South Carolina Small Smiles clinic. A desk audit does notinvolve an onsite audit but instead involves an exchange of docu-ments followed by a review. The desk audit report laid out a num-ber of findings and recommendations for the staff.163
On July 3, 2012, the Independent Monitor followed up with anonsite visit of the Small Smiles clinic in Florence, South Carolina.This site visit occurred almost 4 months after HHS OIG issued itsNotice of Material Breach and Intent to Exclude to CSHM. Whenthe Monitor interviewed the staff and dentists, it was clear thatnone of them was aware of the findings or recommendations fromthe desk audit:
The Compliance Liaison reported she had been in communica-tion with several members of CSHM’s management team anddetermined from their questions there was a report. However,when she asked about it, she was told it had been divided anddistributed by department.164
Additionally, the Independent Monitor found that the clinic con-tinued to perform unnecessary procedures, while failing to diagnoseand treat other problems. In three recorded cases, pulpotomieswere performed without removing the required amount of pulpaltissue, and two patients were fitted with oversized crowns.165 Therecords also indicated that a patient’s mesial decay wentundiagnosed and a single surface occlusal amalgam filling wasplaced on the tooth leading to further decay and the need for astainless steel crown.166 Moreover, the Independent Monitor notedthat one associate dentist administered Septocaine to a childyounger than 4 years of age—a practice that has not been approved
by the FDA.167
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168See Independent Monitor Report Lynn, Mass. at 3 (Aug. 2, 2012) (Exhibit 39).169
See id.170 Id.171 Id.172 Id. at 9–10.173 Independent Monitor Report Mishawaka, Ind. at 6 (Oct. 5, 2012) (Exhibit 40).174See id.175See id. (‘‘The Monitor also identified instances of under-treatment and over-treatment that
resulted in lower scores for the Clinic and passing dentists.’’)176 Id.177See id.178 Id. at 23.
2. Lynn, Massachusetts Independent Monitor Report A month after the Florence report, the Independent Monitorfound similar issues with the Lynn, Massachusetts clinic. After re-viewing the post-operative X-rays, the Monitor found five poorlyperformed pulpotomies, where the tissue from the pulp chamberwas not properly removed.168 There was also one record thatshowed a failure to use a local anesthesia when it was required,and two instances where the wrong anesthetic was used.169
Similar to the report from Akron, the Monitor found that 10records did not justify using surface fillings over stainless steelcrowns.170 The Monitor also found 11 records where the same teethwere treated multiple times.171 As was reported in Akron, failing to use the proper filling can result in further decay and multipletreatments to the same tooth.
Despite the continued attention from HHS, the clinic has yet to
fulfill all of the recommendations from the initial 2011 IndependentMonitor review. Following its interviews, document review, andtreatment observations, the Independent Monitor determined that‘‘CSHM had successfully met and implemented 19 of the 29 rec-ommendations’’ from the Independent Monitor’s previous report.172
3. Mishawaka, Indiana Independent Monitor Report
On October 5, 2012, the Independent Monitor’s findings from itsreview of the Mishawaka Small Smiles clinic revealed evaluationdiscrepancies, patient safety concerns, and questions involving medical necessity. As part of its desk audit, the Independent Mon-itor examined a 2012 internal CSHM chart audit by replicating thetesting parameters and initiating its own assessment.173 TheCSHM chart audit ultimately issued passing scores for all three au-dited dentists.174 While concurring in the finding that two dentistspassed,175 the Independent Monitor issued an automatic failure tothe third dentist based on a ‘‘lack of documentation and radio-graphic evidence to support the medical necessity for treat-ment.’’ 176 Notably, prior to the Independent Monitor’s replicatedaudit, CSHM had given this very same dentist a score of 100%, thehighest score of all three audited dentists.177
More disturbing than the discrepancies in the CSHM evaluationsof dentists are the incorrect calculations for administering anes-thesia. In 4 of 15 records reviewed, the Independent Monitor foundmiscalculations of the anesthesia dosage, and, while finding thatthe administered dosage never exceeded the prescribed maximum,the miscalculations ‘‘allowed for the possibility of patient harm.’’ 178 Furthermore, in three of these four miscalculations, a review re-vealed the use of anesthesia ‘‘without the recognition of a total
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179 Id.180See id.181 Id.182 Indiana Health Coverage Programs, IHCP Bulletin at 5 (Apr. 15, 2010) (Exhibit 62).183See Independent Monitor Report Colorado Springs, Colo. at 16 (Nov. 15, 2012) (Exhibit 41).184 Id. at 18.185 Id. at 19.186 Id. at 20.187 Id.
maximum allowable dose . . . regardless of patient weight or age’’and ‘‘no evidence of calculation adjustments for overweight patientsbased on their healthy weight range.’’ 179
The Independent Monitor’s findings also raised questions aboutthe medical necessity of performed care. In 1 of 15 records re-viewed, it was discovered that neither documentation nor X-rayswere provided to justify the medical necessity for a performed pulp-otomy.180 In fact, the review found that along with a complete lackof X-rays to determine the depth of tooth decay, the patient’s filelacked a ‘‘descriptive narrative’’ and ‘‘the digital photographs didnot support the need for a pulpotomy on [said] tooth.’’ 181 Approxi-mately 6–7% of all pulpotomies performed by that clinic would beunnecessary if the records reviewed are a representative sample of the clinic’s business. Taxpayers needlessly spend $100 in Indianaevery time an unnecessary pulpotomy is performed on a Medicaidpatient.182
4. Colorado Springs, Colorado Independent Monitor Report
As late as November 15, 2012, the Small Smiles clinic in Colo-rado Springs was committing violations resembling those found atnumerous other Small Smiles clinics: under-utilization of X-rays,inadequate documentation of medical necessity, questionable proce-dure rationale, and quality of care issues. First, out of 24 recordsreviewed, the Independent Monitor found 5 records containing medically unnecessary X-rays and 12 records revealed evidence of under-utilization of diagnostic X-rays.183
Second, questions of medical necessity also emerged from theColorado Springs Small Smiles clinic. Notably, the IndependentMonitor observed a trend of treatment being provided without diag-nostic X-rays and further found 5 out of 24 patient records lacked‘‘documentation and/or radiographic evidence to support the med-
ical necessity for treatment[s]’’ which included pulpotomies, astainless steel crown, and a 4-surface filling.184 Third, the Independent Monitor review exposed questionable ra-
tionales for performed procedures. Along with finding a trend of under-utilizing stainless steel crowns, the review revealed 5 out of 24 records lacked documentation for choosing to perform multiplesurface filings and not stainless steel crowns.185
Fourth, the review confirmed that, much like its fellow SmallSmiles clinics around the country, quality of care issues were evi-dent in the Colorado Springs clinic. Out of 24 records reviewed, 2patient records lacked an explanation as to why teeth with noteddecay were left untreated.186 Lastly, and of great concern, is that3 out of 24 records revealed that treatment was administered with-out the requisite informed and documented consent.187
These five clinic findings reflect that, despite HHS OIG’s Intentto Exclude and the new ownership structure, CSHM has continued
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188See Phil Cauthon, National advocates for mid-level dental providers meet in Kan., KHINEWS SERVICE (Dec. 5, 2012), http://www.khi.org/news/2012/dec/05/national-advocates-mid-level-dental-providers-meet/.
189Combating the Silent Epidemic: The Shortage of Dentists in America, Staff Care, at 4,
http://www.staffcare.com/pdf/Dentistry-WhitePaper2007.pdf.190U.S. Dep’t of Labor, Bureau of Labor Statistics, Occupational Outlook Handbook, Dentists Job Outlook, http://www.bls.gov/ooh/Healthcare/Dentists.htm#tab-6 (last visited Mar. 22,2013); Clair Gordon, Extreme Dentist Shortage Leads To ‘Dental Therapists’ Filling Cavities,
AOL Jobs [hereinafter Gordon] (Apr. 16, 2012, 2:14 PM), http://jobs.aol.com/articles/2012/04/16/extreme-dentist-shortage-leads-to-dental-therapists-filling-ca/.
191U.S. Dep’t of Labor, Bureau of Labor Statistics, Occupational Outlook Handbook, Dentists Job Outlook, http://www.bls.gov/ooh/Healthcare/Dentists.htm#tab-6 (last visited Mar. 22,2013). Nationwide there are 48.7 million Americans who live in areas with a shortage of dentalcare.
192See id.
to leave patients with decaying teeth untreated, while performing needless surgery on other patients. In other words, CSHM con-tinues to treat a high volume of patients while sacrificing qualitycare and benefitting from the Medicaid system. The needless proce-dures ensure higher reimbursements, while mismanaged treat-ments ensure return visits that require more intensive treatments.What is most disconcerting from these reports is the timing inwhich these violations occurred. Although subpar dental treatmentto children should never be tolerated, it is even more unforgivablewhen it follows admonishment from the Department of Justice andthe Department of Health and Human Services Office of InspectorGeneral.
V. Dental Demographics
When the Committee staff started investigating dental manage-
ment companies, a common refrain emerged: if their businesses didnot employ dentists to provide care to those in need, the Medicaidpopulation would go untreated. As such, we began to take a closerlook into the demographics of today’s dentists. Although it is unde-niable that certain parts of our country, particularly rural areas,have a shortage of dental providers, this same problem plagues allareas where Small Smiles Clinics are found. Ultimately, the cur-rent model is not sustainable, and dentists will not be able to meetthe growing demand for treatment. Thus, maybe it is time to begindiscussing the incorporation of mid-level providers in order to al-leviate the treatment needs of and provide dental care to patients.Mid-level dental providers’ education and skill level would placethem between a dentist and dental hygienist. They would be quali-fied and licensed to perform relatively minor, but common proce-dures, such as cavity fillings and simple teeth extractions.188
According to Oral Health America, the adequate ratio of dentists
to population is 1 to 1,500.189 Today, that ratio is 1 to 2,000 andin some states, such as Washington, the distribution is even great-er having only one dentist for 12,300 people.190 If this uneven dis-tribution is not corrected, the problems will worsen. The U.S. De-partment of Labor, Bureau of Labor Statistics expects the dentalprofession to grow by 21% from 2010 to 2020.191 The potential fora large gap between the number of dentists needed and the numberof dentists practicing is due to a number of variables. First, therewill be a need for more complicated dental procedures for the babyboom generation.192 In addition, each generation is more likely tokeep their teeth than the last, and studies continue to link dental
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193See id.194Dep’t of Labor, Dentists Job Outlook; The State of Children’s Dental Health: Making Cov-
erage Matter, The Pew Center on the States (May 2011), 208, 209, and 210; Louis W. Sullivan, Dental Insurance, but No Dentists, N.Y. TIMES [hereinafter Sullivan], Apr. 8. 2012, http://www.nytimes.com/2012/04/09/opinion/dental-insurance-but-no-dentists.html? l r=2&.
195The State of Children’s Dental Health: Making Coverage Matter, The Pew Center on theStates (May 2011).
196Gordon. The 2003 and 2004 data is the latest available when the article was written.197Sullivan.198 I–Team: Small Smiles Investigation, http://www.youtube.com/watch?v=pIoMaw4zC9Q
(last visited Mar. 22, 2013). In a similar news story a, 24-year-old single father, Kyle Willis diedof a brain infection that was the result of untreated tooth decay. Gretchen Gavett, Tragic Re-
sults When Dental Care Is Out of Reach, PBS (June 26, 2012, 9:50 PM), http://www.pbs.org/wgbh/pages/frontline/health-science-technology/dollars-and-dentists/tragic-results-when-dental-care-is-out-of-reach/.
199Sullivan.200 Id. Dental disease is the number one chronic child disease that creates more children need-
ing medical care than asthma. Id. In Maine a recent report has indicated that 55 percent of MaineCare children go without dental care even though they have insurance, resulting in moremoney being spent on fixing dental problems that preventing them. Report Details Dental CareShortage in Rural Maine, Boston Globe (Feb. 5, 2013), http://www.boston.com/news/local/maine/2013/02/05/report-details-dental-care-shortage-rural-maine/NkYZrj1bb1OEMKGFQZ1E5O/story.html.
201Sullivan.202Gordon.203See U.S. GOV ’T A CCOUNTABILITY OFFICE, GAO–11–96, ORAL HEALTH: EFFORTS UNDER W AY
TO IMPROVE CHILDREN’S A CCESS TO DENTAL SERVICES, BUT SUSTAINED A TTENTION NEEDED TO A DDRESS ONGOING CONCERNS 12 (2010) (Exhibit 60).
health with overall health.193
Also, 5.3 million more children willqualify for dental services under the Affordable Care Act.194 How-ever, ‘‘without changes in state policies, expanded coverage is un-likely to translate into more dental care for every child in need.’’ 195 Children’s susceptibility to tooth decay is particularly problematic,because dental problems starting at a young age will compoundinto larger problems through adulthood.
The lack of care for both children and adults has resulted in 27percent of children and 29 percent of adults having untreated cav-ities in 2003 and 2004.196 The risks of untreated dental conditionsare not confined to poor oral health, but can have devastating ef-fects on overall health. Many Americans end up in the emergencyroom from tooth abscesses that keep them from eating or cause aninfection that can travel to the brain and kill.197 This horrifying re-sult of tooth decay was the impetus for the ABC–7 I–Team inves-
tigative report into the Small Smiles clinics. The report identifieda 12-year-old Maryland boy, Deamonte Driver, who died of a braininfection resulting from tooth decay that was not properly treat-ed.198
In 2009, more than 830,000 visits to the emergency room nation-wide were the result of preventable dental problems.199 In Floridaalone the bill exceeded $88 million.200 Although many of theseproblems can be solved by preventive measures, the fundamentalproblems of lack of care and substandard care persist.201
As more dentists graduate from school with an average debt of $181,000, with one out of five exceeding $250,000,202 it is less eco-nomical for dentists to open practices in rural areas. Compounding the problem is available data which suggests low dentist participa-tion in Medicaid,203 and the fact that some of those clinics that areproviding care to Medicaid patients, such as Small Smiles, are
doing so at a substandard level. The cost of correcting dental prob-lems is much more expensive than the preventive measures, but
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204Sullivan. Kansas, New Mexico, and Vermont are also debating legislation that would cre-ate similar training programs; Gordon.
205Gordon.206See A M. DENTAL A SS’N, BREAKING DOWN B ARRIERS TO ORAL HEALTH FOR A LL A MERICANS:
REPAIRING THE T ATTERED S AFETY NET 16 (2011); see also A M. DENTAL A SS’N, BREAKING DOWN B ARRIERS TO ORAL HEALTH FOR A LL A MERICANS: THE ROLE OF WORKFORCE 11 (2011) (‘‘[A] crit-ical attribute that the ADA opposes unequivocally: Allowing non-dentists to perform surgical
procedures, often with little or no direct supervision by fully trained dentists.’’).
clearly the cost of providing preventive measures is not cheap oreasy in certain parts of our country.To address dental care access problems, two states have taken
novel approaches to immediately address the lack of dental care. Alaska and Minnesota have been training dental therapists whoprovide fewer services than a dentist and more than a dental hy-gienist.204 These dental therapists are able to perform basic dentalprocedures that are in great demand, such as filling cavities andextracting childrens’ primary teeth.205 These training programs areshorter than dentistry school, and the therapists receive pay thatis roughly half of what a dentist would receive. This program hasopened up dental care in rural areas of Minnesota and Native vil-lages in Alaska. The ADA has opposed these positions out of fearthat mid-level providers will provide substandard care.206
VI. Recommendations
Recommendation 1: HHS OIG should exclude from partici-pating in the Medicaid program CSHM, Small Smilesclinics, and any other corporate entity that employs afundamentally deceptive business model resulting in asustained pattern of substandard care.
• Despite a change in ownership and repeated professed im-provements, CSHM and Small Smiles clinics continue to oper-ate under fundamentally deceptive contracts that circumventstate laws passed to ensure licensed dentists own dental prac-tices, and thus, that the owners are held accountable to main-tain a professional standard of care. As a result, Small Smilesclinics continue failing to meet basic quality and compliancestandards, providing unjustified and deficient procedures, im-properly withholding and recklessly administering anesthesia,and performing dubious internal audits. All of these actionsstrain the Medicaid system. Excluding CSHM and companieswith similarly deceptive ownership structures from the Med-icaid program would deter companies from engaging in similaregregious behavior in the future.
Recommendation 2: States should enforce existing lawsagainst the corporate practice of dentistry and, whereappropriate, take enforcement action against those thatviolate the law.
• State authorities have either ignored or been oblivious to den-tal management services agreements like those used by CSHMthat allow companies to operate dental clinics under the guiseof providing administrative and/or financial management sup-
port.
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•
In the 22 states and the District of Columbia that ban cor-porate dentistry, appropriate action should be taken to elimi-nate such circumvention of the law.
Recommendation 3: If states consider licensure of mid-leveldental providers, such as dental therapists, the FederalGovernment should allow them to be reimbursed by theMedicaid program.
• According to GAO findings, the dental profession has low Med-icaid participation rates and thus has failed to provide neededcare and treatment to lower-income individuals in Medicaid.While struggling to encourage the providers to adequately par-ticipate and serve the Medicaid program, the dental professionhas done little to curb the abuses described in this report.
• States have already begun creating mid-level dental providers,
such as dental therapists, and licensing them to practice intheir states in order to better meet the unmet needs of theirpopulations.
• Some in the dental profession argue that ‘‘low Medicaid reim-bursement rates’’ are the root cause of the types of abuses de-scribed in this report. Yet, the dental profession has also op-posed allowing mid-level providers into the program who couldprovide much of the needed care at the current reimbursementrates.
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