Disclosing drug and alcohol related data

I’ve heard from trustworthy sources that in its Medicare and Medicaid research data files, CMS is no longer including claims for patients with certain alcohol and drug use disorder related diagnoses and procedures. I have not found anything online that documents this more fully. I will update this post should anything come to my attention.

Here’s an email from ResDAC:

email ResDAC

Suffice it to say, lack of access to such data for research is harmful to work on these specific populations, but also any other work, since it imposes a systematic bias on the sample. It messes up risk adjustment too.

Think about it. Think about the precedent it sets as well.

For this reason, I reviewed this entry in the code of federal regulations. At the time I accessed that link, the page said the information was current as of December 3, 2014. I’m having trouble assessing if it was published earlier than that date. I’ve excerpted some key passages below. I’ve added bold to some text. With regard to the issue at hand, I think it speaks for itself. (Update: Maybe they don’t speak for themselves as clearly as I thought. You should read this Nicholas Bagley post for an interpretation of the regulations. All posts on this issue are under the CMS-SUD tag.)

From section 2.1, subsection (a):

Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.

Subsection (b) includes:

(2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows: […]

(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner.

Further on, it reads, in subsection (e):

The prohibitions of this section do not apply to any interchange of records—

(1) within the Armed Forces or within those components of the Veterans’ Administration furnishing health care to veterans

Section 2.2, as near as I can tell, has identical language to 2.1 but pertaining to “alcoholism or alcohol abuse education, training, treatment, rehabilitation, or research.”

Section 2.3 includes

(2) These regulations are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to insure that an alcohol or drug abuse patient in a federally assisted alcohol or drug abuse program is not made more vulnerable by reason of the availability of his or her patient record than an individual who has an alcohol or drug problem and who does not seek treatment.

From section 2.52:

(a) Patient identifying information may be disclosed for the purpose of conducting scientific research if the program director makes a determination that the recipient of the patient identifying information:

(1) Is qualified to conduct the research;

(2) Has a research protocol under which the patient identifying information:

(i) Will be maintained in accordance with the security requirements of §2.16 of these regulations (or more stringent requirements); and

(ii) Will not be redisclosed except as permitted under paragraph (b) of this section; and

(3) Has provided a satisfactory written statement that a group of three or more individuals who are independent of the research project has reviewed the protocol and determined that:

(i) The rights and welfare of patients will be adequately protected; and

(ii) The risks in disclosing patient identifying information are outweighed by the potential benefits of the research.

(b) A person conducting research may disclose patient identifying information obtained under paragraph (a) of this section only back to the program from which that information was obtained and may not identify any individual patient in any report of that research or otherwise disclose patient identities.

Finally, if you’re interested, section 2.16 says, in its entirety:

(a) Written records which are subject to these regulations must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use; and

(b) Each program shall adopt in writing procedures which regulate and control access to and use of written records which are subject to these regulations.


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