Proposed CN Rules on Hospital Change of Control & Transparency

The Washington State Department of Health recently released its proposed rules and letter to Governor Inslee with regard to his directive to open rule making on the Certificate of Need (“CN”) hospital change of control regulations and transparency.  The catalyst for these modifications is the recent spate of affiliations among Washington state hospitals.  The Department of Health was instructed to consider “how the structure of affiliations, corporate restructuring, mergers, and other arrangements among health care facilities result in outcomes similar to the traditional methods of sales, purchasing and leasing of hospitals.”  The current rules require a CN for any “sale, purchase, or lease” of a hospital, but does not provide a definition to explain what is encompassed by a “sale, purchase, or lease”.   The Department of Health has issued its proposed rules creating a definition of “sale, purchase, or lease” in WAC 246-310-010 as follows:

“Sale, purchase, or lease” means any transaction in which the control, either directly or indirectly, of part or all of any existing hospital changes to a different person including, but not limited to, by contract, affiliation, corporate membership restructuring, or any  other transaction.”  WAC 246-310-010(54) (proposed)

The Governor’s directive also focused on transparency for consumers:

The Department’s rulemaking process shall also consider ways to improve transparency for consumer information and ease of use, specifically the Department shall ensure hospitals supply non-discrimination, end of life care and reproductive health care policies; and the Department shall ensure that consumers have access to the policies on its webpage. The Department’s rulemaking process shall also consider the factors in RCW 43.06.155, the principles and policies in the implementation of health reform, including the guarantee of choice for patients.

As a result of comments received from stakeholders, the Department of Health determined that the submission and posting of hospital access policies should be located in the hospital licensing rules, rather than in the CN rules.  The proposed rules suggest adding new provisions to the hospital licensing regulations, specifically WAC 246-320-141 governing patient rights and organizational ethics:

(5) No later than sixty days following the effective date of this section, every hospital must submit to the department its policies related to access to care:
(a) Admission;
(b) Nondiscrimination;
(c) End of life care; and
(d) Reproductive health care.
(6) The department shall post a copy of the policies received under subsection (5) of this section on its web site.
(7) If a hospital makes changes or additions to any of the policies listed under subsection (5) of this section, it must submit a copy of the changed or added policy to the department within thirty days after the hospital approves the changes or additions.
(8) Hospitals must post a copy of the policies provided under subsection (5) of this section to its own web site where it is readily accessible to the public, without requiring a login or other restriction.
The Department of Health is soliciting feedback and hosting a hearing on November 26, 2013 at 1 PM to review the proposed rules.  It expects to file permanent rules on December 10, 2013.
If you have any questions regarding these proposed rules or Certificate of Need in general please contact Elana Zana.

Washington Certificate of Need Program Commences Rule Making: Consumer Transparency in Affiliations & Dialysis

The Washington State Certificate of Need Program has announced its commencement of the rule-making process related to hospitals and dialysis.  This action is in response to the directive issued last month by Governor Inslee instructing the CN Program to expedite rule making related to the corporate restructuring, affiliations, acquisitions and mergers occurring in hospitals across the state.  His directive requires that:

The Certificate of Need process should be applied based on the effect that these transactions have on the accessibility of health services, cost containment, and quality, rather than on the terminology used in describing the transactions or the representations made in the preliminary documents.

The Department’s rulemaking process shall also consider ways to improve transparency for consumer information and ease of use, specifically the Department shall ensure hospitals supply non-discrimination, end of life care and reproductive health care policies; and the Department shall ensure that consumers have access to the policies on its webpage. The Department’s rulemaking process shall also consider the factors in RCW 43.06.155, the principles and policies in the implementation of health reform, including the guarantee of choice for patients.

In response to this directive, the CN Program has released concept rules to implement the directive.  These concept rules contain two significant modifications:

1.  A new defined term in WAC 246-310-010: “Sale, purchase, or lease” means any transaction in which the control, directly or indirectly, of part or all of any existing hospital changes to a different person, including but not limited to by contract, affiliation, corporate membership restructuring, or any other transaction.

This change is significant, as the “sale, purchase, or lease” of all or part of an existing hospital is subject to the CN rules and review.  The new definition expands the applicability of the CN rules and review.  Whereas previously affiliations were typically reviewed under Determinations of Reviewability, the expanded definition would subject such transactions to CN approval.

2.  A new section which collects hospital policies, maintains the policies and list of limitations on certain services online, and requires all hospitals to submit these policies and lists within 60 days of the effective date of the new rule.  The proposed new section is reproduced below:

New Section WAC 246-310-XXX Collection of Hospital Policies

1) Every hospital must submit to the department its following policies related to access to care:

a) Admission;

b) Non-discrimination;

c) End of life care; and

d) Reproductive health care.

2) If the effect of one or more of a hospital’s policies required under subsection (1) of this section limits or excludes access to services authorized by law, the hospital must submit to the department a list of services that are limited or not available at the facility.

3) The department shall post a copy of the policies received under subsection (1) of this section and lists received under subsection (2) of this section on its website.

4) If the hospital makes changes to any of the policies listed under subsection (1) of this section, it must submit a copy of the changed policy to the department within thirty days after the hospital approves of the changes.

5) No later than sixty days following the effective date of this rule each hospital must submit to the department the documents identified under subsections (1) and (2) of this section.

These proposed rules will have an impact on future transactions and existing hospitals.  The proposed revisions will be discussed at an August 5th workshop located at the Department of Health.

If you would like further information about these proposed rules or certificate of need in general please contact Elana Zana.