Within 12VAC5-230-610 the Department of Medical Assistance Services (DMAS) has concerns with the following proposed amendment:

Exception: When there are facilities that have been in operation less than three years one year in the health-planning district, their occupancy can shall be excluded from the calculation of average occupancy if the facilities had an annual occupancy of at least 93% in one of its first three years of operation.

The Department is concerned with the change from permissive to mandatory language. DMAS believes this change will cause an unintended and undesired consequence. When two or more facilities apply for a certificate of public need (COPN) and the certificate is only issued to one facility, the other applicant(s) could simply wait and reapply for a certificate. The occupancy of the facility that was issued a certificate would be excluded from the calculation, which means the newly built facility would not have had a chance to ramp up to meet the previously identified need. This would allow a calculated identified need to stand for two application periods. During the second application period, the certificate that was issued to meet the need would not be taken into account.

DMAS suggests changing the language in the following manner:

Exception: When there are facilities that have been in operation less than three years one year in the health planning district, their occupancy [can shall] be excluded from the calculation of average occupancy if the facilities had an annual occupancy of at least 93% in one of its first three years of operation.

Allowing the exception to be permissive once again.

I am writing on behalf of HCA Virginia regarding the proposed amendments to 12VAC5-230-10 and 12VAC5-230-420 of the State Medical Facilities Plan (“SMFP”) published in the January 8, 2018 Virginia Register of Regulations.

HCA Virginia asks that the Virginia Department of Health (“VDH”) make clear that the final regulations would only be used prospectively for purposes of making decisions on future certificate of public need (“COPN”) applications to introduce cardiac catheterization services submitted after the effective date of the final regulations, and that the final regulations would not be used retrospectively to limit the operations of cardiac catheterization providers authorized to provide cardiac catheterization services prior to the effective date of the final regulations. 

The SMFP is not intended for, and has not historically been used for, oversight of health care providers’ operations.  Instead, the SMFP is intended for, and has historically been used for, evaluation of “projects,” as defined in the COPN law.  “Project” includes introduction of cardiac catheterization services and the addition of medical equipment for the provision of cardiac catheterization, and VDH 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 (provided today by e-mail to Ms. Winstead).

Thank you for considering these comments.  Please contact me if you have questions about these comments.         

Thomas J. Stallings
Partner
McGuireWoods LLP
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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