STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE ADMINISTRATION,

Petitioner,

vs.

VALARY CAMPBELL,

Respondent.

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) Case No. 12-0799MPI

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RECOMMENDED ORDER

On May 16, 2012, Robert E. Meale, Administrative Law Judge of the Division of Administrative Hearings, conducted the final hearing by videoconference in Tallahassee and Miami, Florida.

APPEARANCES

For Petitioner: Jeffries Duvall, Esquire

Assistant General Counsel

Agency for Health Care Administration Fort Knox Building 3, Mail Stop 3 2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent: Randy A. Fleischer, Esquire

Law Offices of Randy A. Fleischer, P.A. 8258 State Road 84

Davie, Florida 33324 STATEMENT OF THE ISSUES

The issues are whether, contrary to section 409.913, Florida Statutes, and Florida Administrative Code Rule

59G-9.070, Respondent has committed violations in core- competency training for nine employees (Eula Brown, Natasia Bernard, Lorine Smiley-Lewin, Taneish Mayers, Irene Thompson, Therese Etienne, Adrae McCalla, Marline Ford, and

Cynthia Phinn), "medication administration/validation training" for seven employees (Ms. Bernard, Ms. Smiley-Lewin, Ms. Mayers, Ms. Thompson, Ms. Etienne, Ms. Ford, and Ms. Phinn), service authorizations for two consumers (J. B. and L. H.), and Level 2 background screening and HIPAA training for one employee

(Ms. Ford).

If Respondent is guilty of any of these violations, an additional issue is the fine that should be imposed.

PRELIMINARY STATEMENT

On January 18, 2012, Petitioner mailed to Respondent a letter stating that it intended to impose a fine of $20,000 for the violations listed in the Statement of the Issues.

Respondent timely requested a formal hearing.

At the hearing, Petitioner called two witnesses and offered into evidence seven exhibits: Petitioner Exhibits 1-6 and 12.

Respondent called one witness and offered into evidence five exhibits: Respondent Exhibits 4-6, 8, and 10. All exhibits were admitted.

The court reporter filed the transcript on June 19, 2012. The parties filed proposed recommended orders on July 6, 2012.

FINDINGS OF FACT

1. At all material times, Respondent owned half of the shares of Glory House USA, Inc., which, for ten years has operated one or more group homes for the developmentally disabled. At all material times, Respondent has been a Medicaid provider of services under the Florida developmental disabilities waiver program. For 2011, Respondent received

   $790,367.16 in Medicaid reimbursements for services provided to

   
   

   1. Medicaid consumers.

      
      

2. At all relevant times, Respondent has been subject to a Medicaid Provider Agreement. In this agreement, Respondent agreed to comply with all federal, state, and local laws, including rules, regulations, and statements of policy applicable to the Medicaid program. In particular, Respondent agreed to comply with Petitioner's Medicaid handbooks.

3. On September 29, 2011, Petitioner's inspectors conducted an unannounced inspection of Glory House. During the course of the inspection, Petitioner's inspectors spoke to Respondent's home manager, who answered the inspectors' questions, supplied all of the requested documents that were readily available, and took the inspectors on a tour of the facility.

4. The Medicaid Developmental Disabilities Waiver Services Coverage and Limitations Handbook issued by Petitioner,

   
   

   effective May 2010 (Medicaid Handbook) Appendix A identifies the assurances required by Petitioner and the Agency for Persons with Disabilities (APD) of providers of services under the Developmental Disabilities Home and Community-Based Services Waiver. Appendix A Section 2.1 imposes specific training requirements on providers and their employees. Appendix A Section 2.1.G imposes the requirement of core competency training upon "[a]ll direct service providers . . . within 90 days of employment."

5. As of the date of the inspection, seven employees, who had been employed by Respondent's corporation for over 90 days, had not completed direct-care core competency training:

   Ms. Brown, Ms. Bernard, Ms. Smiley-Levin, Ms. Mayers,

   
   

   Ms. Thompson, Ms. Etienne, and Ms. Phinn. Petitioner has thus proved seven of the nine alleged violations of this training requirement.

6. Respondent's corporation employed Ms. Ford in July 2011, so she was still in her first 90 days of employment at the time of the inspection and was not yet required to have completed her core competency training. Petitioner seems to have relied on an earlier date shown in Petitioner Exhibit 3, but this date purports to show the date of the employee's application, not the date of hire. The only evidence of

   Ms. Ford's hire date is the testimony of Respondent's daughter,

   
   

   who is the assistant administrator, and she places the date of hire in July 2011.

7. Ms. McCalla had completed the required training prior to the site inspection. Certificates documenting this training show that Ms. McCalla completed the APD Core Competency Training I on September 14, 2006, and APD Core Competency Training II on September 19, 2006. For the two reasons noted in the Conclusions of Law, it is irrelevant that Respondent may not have provided the certificate to the inspectors at the time of the inspection, so the Administrative Law Judge declines to make a finding of fact on whether Respondent provided these certificates to Petitioner at the time of the inspection or within the 15 additional days allowed by the inspector for the provision of documents, as noted below.

8. On the other hand, Respondent's argument that core competency training was only required of employees providing unsupervised direct care to consumers is unsupported by the above-cited provision of the Medicaid Handbook.

9. The allegation as to "medication administration/validation training" is a composite allegation. As noted in the Conclusions of Law, certain employees of providers must undergo medication administration training and validation; these are separate requirements. Also, there is no

   
   

   requirement of "validation training," as suggested by Petitioner's allegation.

10. As of the date of the inspection, six of the seven named employees had completed medication administration training. Ms. Ford was the only employee who had not completed medication administration training, but she did not, at the time, administer medication to consumers or supervise their self-administration of medication. As explained in the Conclusions of Law, the Administrative Law Judge has rejected Petitioner's claim that Respondent had to affirmatively designate those employees who were not allowed to administer medications or supervise the self-administration of medications, so the Administrative Law Judge declines to make a finding of fact on whether Respondent so designated any such employees. Petitioner has thus failed to prove any of the seven alleged violations of this training requirement.

11. As of the date of the inspection, three of the seven named employees had current validations for medication administration: Ms. Mayers, Ms. Etienne, and Ms. Phinn. (Like Ms. Ford, though, Ms. Etienne did not, at the time, administer medication to consumers or supervise their self-administration of medication, so Petitioner's proof as to Ms. Etienne fails on two grounds.) Because, as noted above, Ms. Ford was not designated to administered medications or supervise the self-

    
    

    administration of medications, Petitioner has thus proved three of the seven alleged violations of the validation requirement: Ms. Bernard, Ms. Smiley-Lewin, and Ms. Thompson lacked the required validations.

12. As of the date of the inspection, one employee--the peripatetic Ms. Ford--had not completed HIPAA training. However, the record fails to establish the specific details of this requirement. In its proposed recommended order, Petitioner has relied on two documents: the Non-Institutional Medicaid Provider Agreement (Petitioner Exhibit 1, p. 16), which states only: "The provider agrees to comply with local, state, and federal laws, as well as rules, regulations, and statement of policy applicable to the Medicaid program, including the Medicaid . . . Handbooks . . . "; and the Medicaid Handbook, which states:

    Florida Medicaid has implemented all of the requirements contained in . . . HIPAA. [A]ll Medicaid providers, including their staff . . ., must comply with HIPAA privacy requirements. Providers who meet the definition of a covered entity according to

    HIPAA must comply with HIPAA Electronic Data Interchange (EDI) requirements. . . .

    
    

    For the reason noted in the Conclusions of Law, Petitioner has failed to prove its alleged HIPAA-training violation.

13. As of the date of the inspection, Ms. Ford had submitted unspecified documentation sufficient to allow the

    
    

    Department of Children and Family Services (DCF) to issue a letter, dated June 29, 2011, documenting "the final results of a criminal history records check received by [DCF], required by Florida Statute for the below stated program," which is noted as an "APD Foster/Group Home." The letter further states: "[DCF] received the complete criminal history records for [Ms. Ford].

    Nothing was found in the Department's review that disqualifies the individual from serving in the program . . . for which this screening was requested and is required by law." The letter adds that "[t]his screening remains valid for five years providing the applicant does not have a 90 day break in service "

14. The Medicaid Handbook, at page 55, states:

    
    

    Direct service provider applicants must comply with the requirements of a level 2 screening in accordance with section 435.04,

    F.S. Compliance with this requirement may be accomplished through one of two ways:

    
    

    ●Background screening pursuant to

    s. 393.0655, F.S., or Applicants must submit a fingerprinting card, an affidavit of good moral character, a caretaker information sheet, and a check . . . to DCF for processing. . . . The results of this screening will be submitted with the Medicaid enrollment application.

    
    

    ●Background screenings pursuant to section 409.907, F.S. Applicants must submit a fingerprint card with the Medicaid Enrollment Application and a check made payable to the Medicaid fiscal agent for processing; or, if available, the applicant

    
    

    may submit the screening through an approved live scan location.

    
    

    Screening is performed at the time of enrollment and every five years thereafter. It is the responsibility of the applicant or provider to ensure this request for screening or rescreening is submitted for processing in a timely manner.

    
    

15. Assuming that the cited provisions impose any duty upon Respondent beside ensuring that the employee or prospective employee timely submits her request for screening or rescreening, it is difficult to understand how Ms. Ford's screening document fails to satisfy the second alternative in the first bulleted paragraph. It certainly appears that

    Ms. Ford submitted the required items to DCF for processing, and DCF found nothing to prevent her employment at Glory House.

    Further confirming its responsiveness to the screening requirement in the Medicaid Handbook, the DCF letter even notes that it is good for five years. Petitioner has thus failed to prove its alleged screening violation.

16. Medicaid Handbook Appendix A Section 3.6.E states that a provider may "[b]ill for only those services for which an approved service authorization has been received. Copies

    of service authorizations shall be kept on file by the provider and shall be made available to APD, [Petitioner], or their authorized representatives for monitoring purposes."

    
    

17. As of the date of the inspection, L. H. and J. B. had current service authorizations. The terms of these authorizations were July 1, 2011, through June 30, 2012. Petitioner has thus failed to prove the two service authorization violations.

18. By letter hand delivered to the home manager on September 29, 2011, Petitioner provided Respondent with an additional 15 days to provide, among other things, all employee records, including level 2 background screens. The letter is not free from ambiguity, largely because it is a form for use in a Medicaid-overpayment case that, in this case, covers a list of items that Respondent needed to provide Petitioner following the inspection. In any event, the letter cannot be interpreted as extending the time for compliance with the underlying requirements. In other words, if an employee obtained a medical administration validation on October 5, 2011, it would not obviate the violation. As the Administrative Law Judge noted at the hearing, such an interpretation of the letter would enable providers to ignore many Medicaid program requirements until Petitioner conducted an inspection and then avoid any sanctions by belatedly coming into compliance--after the inspection uncovered violations.

19. There is no indication of prior offenses by Respondent under the Medicaid program. Thus, as defined in the rule

    
    

    discussed in the Conclusions of Law, the ten proved violations all are a first offense for the purpose of identifying the proper fine per violation.

    CONCLUSIONS OF LAW

    
    

20. The Division of Administrative Hearings has jurisdiction. §§ 120.569, 120.57(1), and 409.913(31), Fla.

    Stat.

    
    

21. Section 409.913(15)(e), Florida Statutes, authorizes

    
    

    Petitioner to seek any remedy provided by law if a provider fails to comply with any provision in the Medicaid Handbook, the provider agreement, or any Florida or federal statute, rule, or regulation. Section 409.913(16)(c) authorizes Petitioner to impose a fine of up to $5000 for each act described in Section 409.913(15).

22. Florida Administrative Code Rule 59G-9.070(3)(q) defines a "violation" as any "omission or act" contrary to the Medicaid laws. Rule 59G-9.070(7)(e) provides a fine of $1000 per violation, if a first offense, for a failure to comply with Medicaid laws. Rule 59G-9.070(3)(h) defines an "[o]ffense" as all of the violations contained in an audit report. Rule

    59G-9.070(4)(d) limits the cumulative fine to $20,000 resulting from a case that involves only "violations" that constitute a first offense and does not involve an alleged overpayment.

    
    

23. Florida Administrative Code Rule 59G-13.083 applies to Medicaid providers of developmental disabilities waiver services. As in effect at the time of the September 2011 inspection, rule 59G-13.083(2) incorporated the May 2010 edition of the Medicaid Handbook into rule 59G-4.001, which requires that all Medicaid providers comply with their service-specific coverage and limitations handbook.

24. Petitioner must prove the material allegations by clear and convincing evidence. Dep't of Banking & Fin. v.

    Osborne Stern, Inc., 670 So. 2d 932, 935 (Fla. 1996).

    
    

25. The requirement of core competency training is imposed by Medicaid Handbook Appendix A Section 2.1.G directly on the "provider and its employees," as stated by the above-cited introductory provision of Section 2.1.G.

26. It is irrelevant whether Respondent failed to produce Ms. McCalla's core-competency certificate during the inspection or in the additional 15 days allowed by the letter of

    September 29, 2011. First, Petitioner has predicated its core- competency allegations on Appendix A Section 2.1.G, which is a requirement of training, not documentation of training. Second, even if Section 2.1.G spoke in terms of documentation, the present proceeding is de novo, as provided by section 120.57(1)(k), Florida Statutes, and the de novo nature of this proceeding overrides any agency requirement that the provider

    
    

    supply the required documentation during (or shortly after) the inspection. Wistedt v. Dep't of HRS, 551 So. 2d 1236, 1237 (Fla. 1st DCA 1989). When applied to a documentation requirement, Wistedt relieves the regulated party of the requirement of providing documentation prior to the formation of proposed agency action. To avoid a violation, the provider or its employee may produce at hearing the required documentation that was in effect at the time of the date cited by Petitioner as the effective date of the alleged violation.

27. Florida Administrative Code Rules 65G-7.001 and 65G-7.004 address the administration of medication. Rule 65G-7.001(13) defines a "medication assistance provider" as:

    a direct service provider not otherwise licensed to administer medication who has successfully completed an agency-approved training course and has current validation to provide clients with medication administration or to assist clients with self-administration of medication.

    
    

    Pursuant to rule 59G-7.001(30), "validation" is obtained from a physician or registered nurse following a demonstration of competence in administering medication by an unlicensed direct service provider who has completed medication administration training.

28. An employee is required to update her validation annually. Fla. Admin. Code R. 65G-7.004(6). Although the rules do not explicitly so provide, an employee is ordinarily required

    
    

    to complete successfully medication administration training only once: Rule 65G-7.004(7) requires the retaking of medication administration training only if the employee allows her validation to lapse. Implicitly applying to the employer- provider, rule 65G-7.004(6) warns: " An unlicensed provider may not under any circumstances administer or supervise the self- administration of medication before receiving validation or following expiration of an annual validation."

29. The requirements of rules 65G-7.001 and 65G-7.004 are imposed directly on the employee seeking authority to administer medication or supervise the self-administration of medication, and the above-cited prohibition of rule 65G-7.004(6) applies implicitly to the employer-provider. It is irrelevant whether certain employees whose validations were not current at the time of the inspection later obtained their validations. The cited rules are requirements of training and validation, not documentation of training and validation. Also, as noted in these Conclusions of Law, even if the requirements imposed duties of documentation, the operative date for determining compliance is the date of inspection, not the end of the 15-day additional period or any later date.

30. Petitioner argues that Respondent failed to affirmatively designate Ms. Ford as an employee not authorized to administer medications or supervise the self-administration

    
    

    of medications. (This issue is moot as to Ms. Etienne because she had been trained and validated at the time of the inspection.) In support of its argument, Petitioner cites Medicaid Handbook Appendix A Section 3.0.B.3, which states:

    . . . APD requires that each provider type and those providing the services below develop written policies and procedures for the provision of services to recipients under the Medicaid waiver:

    
    

    * * *

    
    

    B. The provider's policies shall address, at a minimum, the following:

    
    

    * * *

    
    

    3. Policies and procedures, which detail the safe administration and handling of medication in order to assure the health and safety of recipients served; if it is the policy of the provider that the provider or the provider's staff should not administer or assist in administration of medication, this should be clearly stated[.]

    
    

31. Petitioner's reliance on this provision from the Medicaid Handbook is misplaced for two reasons. First, by the use of "should," Section 3.0.B.3 fails to state a clear requirement, whose violation may support a fine. The alleged "requirement" that the provider clearly designate staff who are not authorized to administer medication or supervise the self- administration of medication is in actuality merely a recommendation.

    
    

32. Second, unlike the requirement of Section 2.1.G, discussed above, the requirement of Section 3.0.B.3 is not imposed directly on the provider or its staff, in terms of a requirement to which they must conform, but is imposed on the provider in terms of policies that it must adopt. If Respondent has failed to designate affirmatively in written materials those staff who are not authorized to administer medication or supervise the self-administration of medication, Petitioner could have cited this failure to adopt a policy (or procedure) as a violation of Section 3.0.B.3. But Petitioner may not read this provision of Appendix A into Respondent's policy manual and, citing this otherwise-nonexistent policy, attempt to rebut Respondent's defensive claim that Ms. Ford was not authorized to deal with medications.

33. Petitioner has failed to identify the legal grounds for its allegation that Respondent is liable for a failure of Ms. Ford to complete HIPAA training. Relying on provisions that effectively subject the provider to all federal law, including HIPAA, Petitioner has failed to provide Respondent or the Administrative Law Judge with the specific detail of the requirement of HIPAA training, which, at least for Respondent and the Administrative Law Judge, remains buried within myriad federal statutes and regulations. A fine may not be predicated on such vague allegations without violating Respondent's due

    
    

    process rights. See, e.g., Cottrill v. Dep't of Ins., 685 So. 2d 1371, 1372 (Fla. 1st DCA 1996).

34. Even assuming that the cited provisions concerning the alleged violation of the background screening requirement impose duties on Respondent, other than to ensure that the employee timely submits her request for screening or rescreening, Petitioner has failed to prove that the evidence of screening for Ms. Ford is in any respect deficient.

35. Petitioner has failed to prove that Respondent did not have current service authorizations for L. H. and J. B. at the time of the inspection. For the reasons noted above, in these Conclusions of Law, any failure to have the required documentation available at the time of the inspection itself is irrelevant because the documentation was in existence as of that time.

36. Petitioner has thus proved seven violations of the core competency training requirement and three violations of the medication administration validation requirement. These ten violations are a first offense for determining the amount of the fine, which is $1000 per violation.

RECOMMENDATION

It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of

seven violations of the core competency training requirement and three violations of the medication administration validation requirement and imposing a fine of $10,000.

DONE AND ENTERED this 12th day of July, 2012, in Tallahassee, Leon County, Florida.

S

ROBERT E. MEALE

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 2012.

COPIES FURNISHED:

Jeffries H. Duvall, Esquire

Agency for Health Care Administration Fort Knox Building 3, Mail Stop 3 2727 Mahan Drive

Tallahassee, Florida 32308 jeffries.duvall@ahca.myflorida.com

Randy A. Fleischer, Esquire Randy A. Fleischer, P.A.

8258 State Road 84

Davie, Florida 33324 randy@igc.org

Richard J. Shoop, Agency Clerk

Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Elizabeth Dudek, Secretary

Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1

Tallahassee, Florida 32308

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

1. days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 12-000799MPI

Orders for Case No: 12-000799MPI