June 9, 2006

The Executive Director of the Maryland Health Care Commission (MHCC) has requested our advice regarding the application of Section 15-508 of the Maryland Public Ethics Law, Md. Code Ann., State Gov't Title 15 (Supp. 2005) to members of the Primary Percutaneous Coronary Intervention Data Work Group in regard to a pending MHCC procurement to establish and operate a Percutaneous Coronary Intervention (PCI) Data Center. We advise that the activities of the Data Work Group, and its official report and recommendations to MHCC were sufficiently related to the current proposed request for proposals to be viewed as assistance in the drafting of the specifications and would preclude members of the Data Work Group and their employers from submitting proposals in response to the RFP.

MHCC is an independent agency in the Department of Health and Mental Hygiene. It is responsible for carrying out the provisions contained in the Health-General Article, Section 19-103 et seq. MHCC is directed to: (1) "develop health care cost containment strategies to help provide access to appropriate quality health care services for all Marylanders . . ." and (2) "promote the development of a health regulatory system that provides, for all Marylanders, financial and geographic access to quality health services at a reasonable cost. . . ." 1

MHCC is required to adopt a State Health Plan that includes a plan for health care facilities and services as well as a methodology for a "certificate of need ("CON") program" to review applications for proposed changes in health care facilities and services. 2 MHCC is required to review and adopt the State Health Plan every five years. This is consistent with the Legislative findings and purposes stated in Section 19-102:

(a) Legislative findings—The General Assembly finds that the health care regulatory system in this State is a highly complex structure that needs to be constantly reevaluated and modified in order to better reflect and be more responsive to the ever changing health care environment and the needs of the citizens of this State.

(b) Legislative purpose.—The purpose of this subtitle is to establish a streamlined health care regulatory system in this State in a manner such that a single State health policy can be better articulated, coordinated, and implemented in order to better serve the citizens of this State. . . .

Advancements in medical treatment, procedures and technology, require MHCC to review the requirements of the State Plan in terms of the legislative purposes stated above. In the area of treating coronary disease, the technique of angioplasty was developed approximately twenty years ago. It is performed by threading a slender balloon-tipped catheter from an artery in the groin to the troubled artery in the heart. Often "stents" (wire mesh tubes) are used to support the artery after the balloon is used to open the narrowed artery.

With improvements in the technique of angioplasty and expansion of its use during the 1990's, MHCC reviewed the State Health Plan as it related to Cardiac Surgery. The State Health Plan required all PCI services be provided in hospitals that had on-site cardiac surgery capabilities. In 1996, the MHCC approved a limited exemption permitting hospitals without on-site cardiac surgery units to perform "primary" (meaning emergency and non-elective) PCI on certain patients with acute myocardial infarction. The exempted hospitals had to perform the PCI services in accord with a research project that was testing the hypothesis that primary PCI services could be performed safely by hospitals without on-site cardiac surgery units. Data was collected as part of this project and continued to be collected as a clinical registry when the research phase of the project ended in 1999. The MHCC created an Advisory Committee on Outcome Assessment in Cardiovascular Care in 2002 to review key State health planning and regulatory policies regarding PCI. The Advisory Committee had several subcommittees addressing various aspects of cardiovascular care. One subcommittee, the Subcommittee on Interventional Cardiology developed recommendations for:

. . . institutional, physician, and program development requirements for a primary PCI program, minimum and optimum annual volumes of procedures for a primary PCI program; patient groups suitable for primary PCI in settings without on-site cardiac surgery; and process and outcome measures for ongoing quality assessment. The subcommittee emphasized the need to monitor the outcomes of care for STEMI patients 3 and recommended that a uniform registry database be developed, implemented, and analyzed from all hospitals in Maryland offering primary PCI services. The Commission adopted the subcommittee's recommendations, which were endorsed by the Steering Committee of the Advisory Committee, as part of COMAR 10.24.17, effective in March 2004. . . . 4

The amended State Health Plan allowed the MHCC to issue a waiver to hospitals without on-site cardiac surgery to conduct primary PCI programs. Subsequently, the MHCC appointed the Data Work Group in 2004 to define a uniform data set to monitor outcomes for patients with ST-segment elevation and to develop recommendations related to the auditing and analysis of the primary uniform data set. There were eight members of the work group who came from various universities, hospitals, and health departments. The work group met a total of five times and produced a final report. The final report included a recommended primary PCI data set, and recommendations for auditing and analysis of the data set. It also recommended to MHCC to establish a data coordinating center to manage the collection, analysis, and auditing of the data and the development of reports. It also recommended the establishment of a data validation committee and a data monitoring advisory group.

Subsequently in 2006, MHCC determined that it would undertake the establishment of the data coordinating center through the use of an outside consultant or contractor. MHCC prepared an RFP that resulted in the Executive Director's request to us regarding the application of §15-508. In the introduction to the RFP, the following was stated:

. . . The MHCC requests proposals to establish and manage a Data Coordinating Center (DCC) for the Maryland Primary Percutaneous Coronary Intervention (PCI) Data Set. The MHCC is seeking the services of a DCC to provide expertise in statistical methods that optimize analyses of clinical registry data. The DCC will provide technical expertise in data collection, validation, and management to produce a valid and reliable database for analyses. The DCC will interact with the primary PCI sites, perform data analyses, prepare and present reports on site performance and outcomes, and participate in meetings . . . page 1 of the RFP

The RFP's Purpose (3.0) clause included the following statement:

. . . The contractor shall assist the MHCC in establishing the DCC, which will provide expertise in the collection, management, and analysis of the Maryland Primary Percutaneous Coronary Intervention (PCI) Data Set. The contractor shall provide date processing and analytic services using these and other data collected by the MHCC (for example, the hospital discharge data set). After editing the primary PCI data, the contractor shall prepare reports that contain data on performance indicators related to patient demographics, history/risk factors, PCI procedures, and adverse events or outcomes. Successful completion of the contract will provide for the data reporting, analysis, and monitoring necessary for specific and uniform measurement of the performance of primary PCI centers and ongoing support of the evaluation and improvement of primary PCI services in Maryland . . .

We have in previous advisory opinions discussed the history of §15-508. 5 This section of the Ethics Law arose from the activities of a legislative Joint Task Force on Maryland's Procurement Law in 1993. The Task Force was directed to consider what safeguards were warranted to prevent abuse or the appearance of improper influence within the procurement system. The Task Force addressed certain ethics aspects of the procurement process. It expressed concern about the conflicts of interest that arise when persons who are not government employees assist an agency in what become specifications for a procurement and are then allowed to submit a proposal for that procurement. The concern is that there is an appearance of improper influence because these individuals are in a position to benefit their own private interests and the interests of their employers. The Task Force recommended legislation, and in 1994 the General Assembly enacted what subsequently became §15-508 restricting individuals who assisted in the drafting of specifications from bidding on the procurement. The Task Force included the following comment in its Final Report:

. . . In recent years, there seems to be a trend toward the creation of ad hoc groups to lend expertise in the procurement process for major and complex contracts. The conflict occurs if an individual has participated in an ad hoc group charged with the development of specifications and requests for proposals or invitation for bids. Such groups...are thus not necessarily precluded from participating in that procurement. Additionally, other examples of potential conflicts arise when a consultant or other interested party participates in the development of findings and recommendations on behalf of an Executive Branch study group, and is in a position to suggest recommendations that may benefit their interests. . . . 6

Our review of the present request is focused on whether the MHCC Data Work Group's final report and recommendations constituted "assistance" in the drafting of specifications for the current MHCC's request for proposals. This is a factual determination judged by all the circumstances. In this regard we find that the Data Work Group's report and recommendations are sufficiently related to the language in the current request for proposals to be viewed as assistance in the drafting of the specifications. While we recognize that some of the recommendations of the Data Work Group are general and perhaps even common sense, we are instructed by the General Assembly in §15-101(c) to liberally construe the Ethics Law to accomplish it purposes. While we are not reflecting on the integrity of any member of the work group, the Ethics Law, in these circumstances, assures the public of the impartiality and independence of government by prohibiting the members of the work group from bidding on the procurement and thereby accomplishes the purpose of avoiding any appearance of improper influence or special advantage.

Julian L. Lapides, Chairman
    Janet E. McHugh
    Robert F. Scholz
    Paul M. Vettori


1 Section 19-103(c)(1) and (2) Md. Code Ann., Health-Gen. II (Supp. 2005)

2 Section 19-118 Md. Code Ann., Health-Gen. II (Supp. 2005)

3 Patients who have an acute ST-segment elevation myocardial infarction (STEMI).

4 Page 1, Interim Final Report of the Primary Percutaneous Coronary Intervention Data Work Group, October 2005.

5 See for example Opinions No. 94-9 and No. 95-13.

6 Report of the Task Force to Study Maryland's Procurement Law, p.31.