Confidentiality of Substance Use Disorder Patient Records
2017-02-07 2016-03-03 2017-02-16 2016-03-04 2016-03-29 2016-04-06 2016-04-10
HHS-OS-2016-0005-0379 HHS-OS-2016-0005-0030 HHS-OS-2016-0005-0392 HHS-OS-2016-0005-0035 HHS-OS-2016-0005-0075 HHS-OS-2016-0005-0121 HHS-OS-2016-0005-0187
05:00:00 05:00:00 05:00:00 05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0379 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0030 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0392 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0035 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0075 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0121 https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0187
Margaretq Dennis Fr. jack Paul Louise Steve William
Chappell Mccarty Kearney Bowman Foote Pierson Rogers
Based on my understanding of the updated rule I read I was very disappointed to see the rules for coordination of care with other health care providers, the sharing information in provision of integrated care and sharing information with health information exchanges was not streamlined - the regulations not reduced or changed for ease in these areas.  We continue to need specific permission from the patient to share this very critical medical information.  Withholding the information from coordination, from health information exchanges, and from the integrated care model causes care for the individual to be compromised.  The rules, from my perspective (someone who has worked with organizations servicing patients for over 30 years) continues to stigmatize the illness of addiction and continues to stigmatize addiction treatment.  Please consider eliminating the rules that require  authorization form the patient to share their treatment information with the providers who are providing treatment and care for the individual - we are providing treatment for the whole individual, not the individual minus the addiction.  This sort of restriction of information sometimes puts the patient at risk, they (the patient) choose not to share their addiction information so their providers or other aspects of their care are not aware of the treatment for addiction or their addiction and are then unable to include that variable in the treatment plan, sometime resulting in contra indicated treatments for the patient. Comments on 42 CFR Part 2: Proposed RuleFile Code SAMHSA 4162-20Section 2.52: Research2.52(a). I support SAMHSAs expansion of authority to disclose patient identifying information for the purpose of conducting scientific research to include other lawful holders of part 2 data.  Data for scientific studies is usually obtained from payer rather than providers.  The proposed language permits continuation of necessary and important scientific research on the effects of alcohol and drug use disorders and the value of treatment for the disorders. SAMHSAs interpretation of the current language as restricting the release to part 2 programs was too narrow and inhibited health services and health economics research.  The standards (2.52(a) (1 - 3)) for releasing data to qualified researchers appear to be reasonable.The restrictions on the use of the data (2.52 (b) (1 - 6) also appear to be reasonable.  SAMHSAs discussion of the proposed revisions to section 2.52 (p. 65 - 72), requests comments on restricting data linkage to federal data repositories. This proposed restriction is much too narrow.  Researchers working with a local drug court, for example, could seek to link part 2 data to criminal justice records.  There is no need to engage a federal data repository if local arrest and court records are sufficient for the investigation.  A university based investigator could readily meet the expected confidentiality, privacy and security safeguards.  Similarly, some health plans place part 2 data in a separate database and data linkages are required to assess associations with healthcare utilization and access.  A commercial health plan, private health care system, or a state agency should be permitted to link their part 2 data for purposes of research and evaluation. The eight standards proposed (page 69  70) are reasonable.  A necessary safeguard could require the data to be de-identified prior to release to an investigator.  As an investigator, I do not want to receive identified data.  It is easier to protect the data from a court order if there is insufficient identifying information in the data set. I know that under the current rule anyone outside of my agency that I refer them to as part of my program (e.g a psychologist) must agree to the same level of protection as they have here. Under the revision, can I reassure my patients that a simple court order signed by a judge is not enough to force the psychologist release information? How must I communicate this to the psychologist?   By not addressing the PDMP issue you are no longer protecting patients who are by lawIn a Protected group. Bupernorphine patients treated by data 2000 waived doctors should he afforded the same protection as a patient being seen in an OTP. This leaves this issue open to law suits by 42 CFR part 2 patients. Who are having anyone look them up and then possibly being descimated in getting a job or Heath care.  Please expand the  SAMHSA  comment period for a period of one year for a more open process.I oppose the changes to 42 CFR PART 2 as currently proposed by SAMHSA. Confidentiality is key to people getting treatment that works! I write on behalf of the American Statistical Association to support the proposed rule change, Confidentiality of Substance Use Disorder Patient Records. As documented in the March 15, 2016 JAMA article, Suppression of Substance Abuse Claims in Medicaid Data and Rates of Diagnoses for NonSubstance Abuse Conditions, the suppression of claims with diagnoses that indicate substance use disorders also suppresses data on conditions that are comorbid with substance use disorders. Thus, suppression adversely affects researchers and policy makers ability to examine not only substance use disorders but several other conditions as well.  The implications of the proposed rule change for data linkage are also important, given the increase in alternative payment models, such as Accountable Care Organizations, and the need to effectively evaluate them. We strongly support the proposed rule be adopted to reverse the deleterious impact of the current suppression of substance abuse-related claims.  I strongly support the proposed rule