March 9, 2018

Domica Winstead

Policy Analyst, Office of Licensure and Certification

Virginia Department of Health

9960 Mayland Drive, Suite 401

Henrico, Virginia 23233

RE:      Proposed Amendments to State Medical Facilities Plan Regulations

Dear Ms. Winstead,

Please accept these comments submitted on behalf of the Virginia Hospital & Healthcare Association (“VHHA”) in reference to the Virginia Board of Health’s proposed amendments to 12 VAC 5-230, State Medical Facilities Plan (“SMFP”) regulations.  These amendments would “correct several definitions in relation to cardiac catheterization, and add some new definitions,” as well as, make changes “to the occupancy standard utilized for determining the need for new nursing home beds.”  

Based upon our review and research, it appears that the proposed regulations regarding cardiac catheterization were previously developed by the SMFP Task Force in 2013.  While it is encouraging to see updates to the SMFP, there have undoubtedly been changes in technology, industry standards, and utilization demands in the past five years, potentially rendering the proposed modifications out of date.  For example, since 2013, there is a higher degree of consensus that right heart catheterizations are an essential part of the standard of care in evaluation of conditions such as pulmonary hypertension and advanced congestive heart failure.  Therefore, we respectfully suggest that an appropriate step would be to re-assign the cardiac catheterization regulations to the SMFP Task Force for review and revalidation before proceeding with the promulgation process.

Additionally, as was a concern raised in 2013 when the proposed changes to the cardiac catheterization regulation were first developed, the requirements related to programs that perform complex therapeutic cardiac catheterizations are more restrictive than current regulatory requirements.  In particular, the proposed regulations state that “Proposals to provide complex therapeutic cardiac catheterization should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed complex therapeutic services will be located.”  See proposed regulation 12 Va. Admin. Code § 5-230-420(B).  This presents the question of whether changes to the SMFP are applied retrospectively to the operations of existing cardiac catheterization programs or whether they apply only prospectively to new applicants. 

It is submitted that the SMFP is not intended for evaluation of “projects,” as defined in the Certificate of Public Need (“COPN”) law.  “Project” includes introduction of cardiac catheterization services and the addition of medical equipment for the provision of cardiac catheterization, and the Virginia Department of Health has previously determined that, unless already-approved cardiac catheterization providers increase their number of cardiac catheterization laboratories or otherwise trigger the definition of “project,” SMFP language does not limit how COPN-approved cardiac catheterization providers can use their approved cardiac catheterization laboratories.  See, e.g., November 15, 2002, letter from Erik O. Bodin, III, Director, DCOPN, to Jeffrey L. Deal, Director, Planning and Marketing, Martha Jefferson Hospital (attached).  It is our understanding that the Division of Certificate of Public Need (“DCOPN”) presented this question to the Office of the Attorney General in 2013.  To our knowledge this question remains unresolved.

In summary, VHHA appreciates that DCOPN is working to update the SMFP with these proposed regulations.  Consistent and timely updates to the SMFP are critical to advancing important policy goals and play an essential role in ensuring sound health planning for the Commonwealth.  However, for reasons discussed above, we respectfully suggest that an appropriate step at this time would be to re-assign the cardiac catheterization regulations to the SMFP Task Force for review and revalidation before proceeding with the promulgation process.  Additionally, it would be helpful to obtain clarification on the retrospective application of changes to the SMFP and impact on existing projects.

Thank you again for this opportunity to comment.

Sincerely,

R. Brent Rawlings

Vice President & General Counsel