HLT-37-11-00017-A Qualified Health Information Technology Entities
2/15/12 N.Y. St. Reg. HLT-37-11-00017-A
NEW YORK STATE REGISTER
VOLUME XXXIV, ISSUE 7
February 15, 2012
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-37-11-00017-A
Filing No. 60
Filing Date. Jan. 27, 2012
Effective Date. Feb. 15, 2012
Qualified Health Information Technology Entities
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of section 504.9 of Title 18 NYCRR.
Statutory authority:
Public Health Law, sections 201 and 206; and Social Services Law, sections 363-a and 365-a(2)
Subject:
Qualified Health Information Technology Entities.
Purpose:
To broaden the definition of a Service Bureau to include Qualified Entities.
Text or summary was published
in the September 14, 2011 issue of the Register, I.D. No. HLT-37-11-00017-P.
Final rule as compared with last published rule:
No changes.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Assessment of Public Comment
The only comments received by the Department on the proposed regulation were submitted by an entity that anticipates applying to be recognized as a Qualified Health Information Technology Entity once the proposed rule is finalized. These comments and the Department of Health's responses are summarized below.
Comment:
The commenter states that the Medicaid enrollment process is designed for health care providers, not health information technology organizations such as Qualified Entities. As a result, this commenter is concerned that the enrollment process may impose unnecessary administrative burdens on Qualified Entities, which will divert limited resources away from their core mission without addressing the legitimate needs of the Medicaid program. In lieu of enrollment, the commenter recommends that the Medicaid program enter into specially tailored agreements with Qualified Entities that focus on the unique role played by these organizations.
Response:
The proposed regulations require Regional Health Information Organizations (RHIOs) or Qualified Entities (QEs) to enroll in the Medicaid program as service bureau providers. As such, RHIOs or QEs can obtain access to Medicaid data and other benefits of Medicaid enrollment in order to disseminate Medicaid data to their participating provider organizations as appropriate. While DOH does not look upon this process as burdensome, we will work with the Medicaid program and the QEs to develop a process that is both efficient and effective and ensure that there is a level playing field as to rules and procedures.
Comment:
This commenter requests a change in wording from "members" to "participants" in paragraph (h)(2) of the proposed regulation, which refers to QEs sharing information with their members. The commenter states that the term "members" suggests a level of ownership or control in the organization.
Response:
While the word "participants" may be more consistent with the terminology used in the New York eHealth Collaborative's Privacy and Security Policies, the intent of the language is the same. No change to the regulation was made in response to this comment.
Comment:
This commenter questions the use of the phrase "informed consent" in paragraph (h)(3)(a) of the proposed regulation, stating that this term is usually used in connection with medical treatment, and not in New York's confidentiality laws. The commenter recommends the term "consent" or "authorization" instead.
Response:
Informed consent connotes an understanding by the medical assistance recipient of what they are consenting to. The New York eHealth Collaborative's Privacy and Security Policies use the term "affirmative consent" for the same reason. The Department considers the terms "informed consent" and "affirmative consent" to be equivalent in this context. No change to the regulation was made in response to this comment.
Comment:
This commenter questions the definition of the term Qualified Entity in paragraph (h)(2) of the proposed regulation and states that the language used could be interpreted as requiring QEs to be listed in the consent form signed by the medical assistance recipient.
Response:
The Department believes the language of the proposed regulation clearly conveys its intent, that disclosures of recipient-specific information to QEs must be made with the consent of the medical assistance recipient. Therefore, no change was made to the regulation in response to this comment.
Comment:
The commenter recommends a change in the language of paragraph (h)(3)(c) of the proposed regulation, to obligate QEs to "require" their members to comply with all applicable confidentiality laws and regulations, rather than to "ensure" that they comply. The commenter is concerned that a QE will be held responsible, and possibly sanctioned, for improper conduct committed by one of its members that is beyond its control.
Response:
The proposed language change does not change the intent of the regulation, and therefore no change to the regulation was made in response to this comment.
