Millennium PPS

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October 14, 2016

Millennium Collaborative Care PPS
Erie County Medical Center
Greg Turner, DSRIP Director
462 Grider Street
Buffalo, New York 14215

Dear Mr. Turner:

On December 15, 2015, the Department of Health (Department), the Office of Mental Health (OMH), and the Office of Alcoholism and Substance Abuse Services (OASAS) were pleased to respond to the request for waivers from certain regulatory requirements submitted by Erie County Medical Center in its capacity as lead for the Millennium Collaborative Care PPS under the Delivery System Reform Incentive Payment (DSRIP) Program. In that letter, we notified you that your waiver request 48.02, related to Shared Space/Colocation, required additional review.

Pursuant to Public Health Law (PHL) § 2807(20)(e) and (21)(e) and in connection with DSRIP Project Plans and projects under the Capital Restructuring Financing Program which are associated with DSRIP projects, the Department, OMH, OASAS and OPWDD may waive regulations for the purpose of allowing applicants to avoid duplication of requirements and to allow the efficient implementation of the proposed projects. However, the agencies may not waive regulations pertaining to patient safety nor waive regulations if such waiver would risk patient safety. Further, any waivers approved under this authority may not exceed the life of the project or such shorter time periods as the authorizing commissioner may determine.

Accordingly, the pending regulatory waiver response below is for projects and activities as described in the Project Plan application and any implementation activities reasonably associated with those activities. The regulatory waiver may no longer apply should there be any changes in the nature of a project. It is the responsibility of the PPS and the providers that have received waivers to notify the relevant agency when they become aware of any material change in the specified project that goes beyond the scope for which the waiver was granted. Further, the regulatory waiver approved is only for the duration of the projects for which it was requested.

The approval of regulatory waivers is contingent upon the satisfaction of certain conditions. In all cases, providers must be in good standing with the relevant agency or agencies. Other conditions may be applicable as set forth in greater detail below. The failure to satisfy any such conditions may result in the withdrawal of the approval, meaning that the providers will be required to maintain compliance with the regulatory requirements at issue and could be subject to enforcement absent such compliance.

Specific pending requests for regulatory waivers included in the Millennium Collaborative Care PPS Project Plan application are addressed below.

2       Millennium Collaborative Care         10 NYCRR 83         3 fi, 4 di

Background and Justification submitted with your request:

Both organizations already have a good working relationship but realize that the best case scenario would be to co–locate. By doing so, both organizations would increase their staff's knowledge, encourage further collaboration, decrease overall costs and expand service provision. Additionally, consumers and human service agencies would know where to go for the critical services these programs provide to new moms and children.

Response to Waiver Request:

Shared Space/Co–location. Please see attached guidance relative to allowable initiatives relative to "Shared Space/Co–Location." No waiver is needed to the extent providers follow the attached guidance. DOH/OMH/OASAS do not have the authority to issue any regulatory waivers beyond what is allowable by federal regulations and policy.

6       Millennium Collaborative Care         10 NYCRR 83         3 fi, 4 di

Background and Justification submitted with your request:

Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a site in the same space as the county. Both clinics will operate separate EHRs.

Response to Waiver Request:

Shared Space/Co–location. Please see attached guidance relative to allowable initiatives relative to "Shared Space/Co–Location." No waiver is needed to the extent providers follow the attached guidance. DOH/OMH/OASAS do not have the authority to issue any regulatory waivers beyond what is allowable by federal regulations and policy.

7       Millennium Collaborative Care         10 NYCRR 401.1, 10 NYCCR 700.2 (a)(22), 10 NYCRR (703.6)         3 fi, 4 di

Background and Justification submitted with your request:

Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a site in the same space as the county. Both clinics will operate separate EHRs.

Response to Waiver Request:

Shared Space/Co–location. Please see attached guidance relative to allowable initiatives relative to "Shared Space/Co–Location." No waiver is needed to the extent providers follow the attached guidance. DOH/OMH/OASAS do not have the authority to issue any regulatory waivers beyond what is allowable by federal regulations and policy.

8       Millennium Collaborative Care         14 NYCRR 599.4 (r), (ab)         3 fi, 4 di

Background and Justification submitted with your request:

Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a site in the same space as the county. Both clinics will operate separate EHRs.

Response to Waiver Request:

Shared Space/Co–location. More Information Needed. 14 NYCRR 599.4 (r) and (ab) are not applicable to the waiver background and justification provided. Please provide further clarification.

In cases where waivers are approved, the agencies will send letters directed to the providers which otherwise would be responsible for complying with the regulatory provisions at issue. Providers further will be advised that agency staff who conduct surveillance activities will be notified that these regulatory waivers have been approved; however, they should maintain a copy of their waiver letters at any site subject to surveillance.

Please note that the Department will continue to publish on its website a list of regulatory waivers that have been approved to assist PPSs in determining whether additional waivers may be appropriate for the activities within a PPS. Additional requests for waivers, as well as any questions regarding the foregoing, may be sent by email to: DSRIP@health.ny.gov with Regulatory Waiver in the subject line.

Thank you for your cooperation with this initiative. We look forward to working with you to transform New York's delivery system.

Sincerely,

Howard A. Zucker, M.D., J.D.
Commissioner
New York State Department of Health

Ann Marie T. Sullivan, M.D.
Commissioner
New York State Office of Mental Health

Arlene Gonzàlez–Sànchez
Commissioner
New York State Office of Alcoholism And Substance Abuse Services