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Karkalas v. Department of State, Bureau of Professional and Occupational Affairs

Commonwealth Court of Pennsylvania

June 11, 2013

Elias Karkalas, M.D., Petitioner
v.
Department of State, Bureau of Professional and Occupational Affairs, State Board of Medicine, Respondent

Submitted: May 3, 2013

BEFORE: HONORABLE BONNIE BRIGANCE LEADBETTER, Judge HONORABLE PATRICIA A. McCULLOUGH, Judge HONORABLE ANNE E. COVEY, Judge

OPINION

ANNE E. COVEY, Judge

Elias Karkalas, M.D. (Karkalas) petitions this Court for review of the Department of State, Bureau of Professional and Occupational Affairs, State Board of Medicine's (Board) September 17, 2012 order imposing a $2, 500.00 civil penalty and requiring him to complete 10 hours of continuing education in the area of medical recordkeeping. The issue for this Court's review is whether the Board erred as a matter of law when it interpreted Section 16.95(a) of the Board's Regulations[1] (the Regulation) to require a physician providing prescription review services to a commercial company to have continuing access to and control over his patients' medical records. We affirm.

The facts in this case are undisputed. Karkalas has held a license to practice medicine and surgery in Pennsylvania since 1981. In 2009, Karkalas contracted with Health Solutions Network, Inc. (HSN), a commercial company also known as a clearinghouse, to review online prescription requests. Pursuant to his contract, Karkalas filled prescription requests based upon HSN's customers' online questionnaires which provided information such as the reason for the request, medical history, and other prescribed medications being taken.

Between July 21, 2009 and September 3, 2009, Karkalas wrote 28 prescriptions for 28 HSN customers for the drug Butalbital. HSN maintained in its secure computer database all related questionnaire information of the individuals for whom Karkalas had written the prescriptions. Karkalas had full access to the online database and could contact an HSN custodian of records for further assistance in accessing patient records. During his contract with HSN and until late fall 2011, Karkalas kept his prescription records only on HSN's centralized database. He did not print or otherwise personally retain prescription records or patient questionnaires. Further, he did not maintain in his office any records, independent files, or even patient names pertaining to the online prescriptions.

At some point in 2011, HSN terminated its contract with Karkalas and discontinued his access to the online database. As a result, Karkalas was unable to obtain the records relating to the prescriptions he had written through HSN. HSN ultimately provided Karkalas with patient records evidencing that, in 2009, he had authorized 28 prescriptions for Butalbital through HSN. However, Karkalas could not verify the accuracy of the records. In the fall of 2011, upon realizing that he might not have access to documents and medical records generated for and maintained by clearinghouses for whom he performed services, Karkalas began to maintain his own records in a secure database in his office.

On April 14, 2011, the Board issued an Order to Show Cause alleging 2, 499 counts that Karkalas had violated the Medical Practice Act of 1985[2] (Act) and the Regulation. The Order to Show Cause specifically alleged that Karkalas had engaged in unprofessional conduct, in that he failed to maintain medical records for 2, 499 patients subjecting him to disciplinary action under Section 41(6) of the Act[3]for violation of the Regulation.

At a March 27, 2012 hearing, the Board issued an amended Order to Show Cause reducing the number of counts to 28. The parties stipulated to the essential facts of the case and the sole issue. On May 14, 2012, the hearing examiner issued her report and order finding that Karkalas had violated the Regulation, and she imposed disciplinary action under Section 41(6) of the Act.

On May 24, 2012, the Board issued a notice of intent to review. On September 17, 2012, the Board issued its order adopting the hearing examiner's findings of fact, concluding that Karkalas had violated the Regulation when he failed to maintain access to and control over his patients' medical records. The Board issued its order imposing a $2, 500.00 civil penalty, and further required Karkalas to complete 10 hours of continuing education in the area of medical recordkeeping. Karkalas appealed to this Court.[4]

Karkalas argues that the Board erred when it held that he violated the Regulation. He claims that the Regulation does not require a physician "to have perpetual 'access to' and 'control over' [a patient's] medical records." Karkalas Br. at 10. He contends that the Board's interpretation of the Regulation ignores the realities of modern medical practice in that many physicians are employed by healthcare systems, hospitals or group practices where the employers and not the physicians maintain patient medical records. Because physicians are generally not permitted to take patient medical records with them when they leave employment, Karkalas asserts that if the Board's interpretation of the Regulation is permitted to stand, the aforementioned trade practices will result in countless physicians violating the Regulation. Accordingly, he argues the Board's interpretation of the Regulation must be erroneous. We disagree.

It is well-established that:
[i]n reviewing an administrative agency's interpretation of its own regulations, courts are governed by a two step analysis. First, in construing administrative regulations, the ultimate criterion is the administrative interpretation, which becomes of controlling weight unless it is plainly erroneous or inconsistent with the regulation. ...

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