Monday, September 16, 2019

Confidently Under Attack

National Alliance for Medication Assisted Recovery
Press Release


Contact Person:
Joycelyn Woods, Executive Director, edirector@methadoe.org
Phone/Fax: 1 (212) 595-NAMA (1-212-595-6262)

For Release:
September 16, 2019

Confidently Under Attack
(We Are in for the Fight of Our Lives)

SAMHSA has posted two notices of proposed rulemaking (“NPRMs”) on the federal regulations for the Confidentiality of Substance Use Disorder Patient Records.

They were published August 26, 2019 in the Federal Register.  Note the comment deadlines for each rule:

NPRM – Regulatory Information Number 0930-AA30:
Deadline for submitting public comments: by 5 pm September 25, 2019

NPRM – Regulatory Information Number 0930-AA32:
Deadline for submitting public comments: by 5 pm October 25, 2019

Number 0930-AA30 public comments must be submitted by September 25, 2019 by 5 pm.

Here is a summary of the main changes that are acceptable:

Consent Requirements: Patients may consent to release without naming a specific person to apply for benefits and resources (i.e. SSI)

Disclosures Permitted w/ Written Consent: Payment and health care operations are permitted with written consent.

Medical Emergencies: Patient information may be released during declared emergencies without consent.

Audit and Evaluation: To resolve current ambiguity, part 2 will be revised to clarify some situations that fall within the scope.

Here is a summary of the main changes that are NOT acceptable:

Applicability and Re-Disclosure: Patient’s records in non-part 2 providers both previous and current are no longer covered.

NAMA-R thinks this is unacceptable and that Part 2 records needs to maintain the protection that they have always had.

Disposition of Records: Part 2 program employees may delete a patient message sent to them on their personal device. 

NAMA-R does not believe Part 2 employees should be using their personal devices for program business. Part 2 programs should set aside the funds to purchase mobile phones for employees.

Disclosures to Central Registries and PDMPs: Non-OTP providers may query a Central Registry to determine if patients are receiving opioid treatment elsewhere. OTPs will be permitted to enroll in PDMPs when prescribing Schedule II to V, consistent with applicable state law.

NAMA-R believes Central Registries are an important part of the treatment system, as they have been for over 40 years, and can be utilized in ways that protect Confidentiality.  However, reporting medication dispensed by OTPs to state prescription drug monitoring programs (PDMPs) would violate the specific consent requirements of 42 USC 290dd-2. Furthermore, it gives criminal justice agencies access to persons involved in substance use treatment.  This could discourage individuals with OUD from seeking treatment. Law enforcement accesses PDMPs at a very high frequency. Many states do not require a warrant or subpoena for law enforcement access of this highly sensitive information. This is a very low bar.

Research: Research may be conducted by HIPAA entities or business associate to individuals and organizations who are not HIPAA entities, nor subject to the Common Rule (re: Research on Human Subjects).

NAMA-R supports research involving patients of SUD treatment as long as confidentiality protections remain in place. These proposed changes will allow research into OTPs in a way that opens the door for entities to do marketing research and otherwise violate a patient’s civil right to confidentiality.

Confidential Communications: To correct an error from the 2017 rule-making, the “standard for court ordered disclosures of SUD records for the purpose of investigating "an extremely serious crime" will be revised, by dropping the phrase "allegedly committed by the patient."

NAMA-R opposes the proposed changes to this section. For over forty years, Part 2 has protected people who have sought treatment for alcohol and drug use from having their own records used against them in courts, unless it is a case of serious violence or child abuse. It has never been intended that our SUD treatment records be used in cases of "drug trafficking" against a patient, or another person. People seek treatment to recover from substance use disorders, to change their lives, and believe that the private information they share will be confidential and protected. One must recall that Part 2 was implemented over a murder that a community person thought was committed by a patient at an OTP. The community member was wrong.

Undercover Agents and Informants: Court-ordered placement of an undercover agent or informant within a part 2 program will be extended to a period of 12 months, and courts will be authorized to extend the period through a new court order.

NAMA-R believes that there is no place for informants in Part 2 programs. Allowing this will frighten prospective patients from treatment during a time of crisis and will obliterate the confidentiality protections required by 42 USC 290dd-2.

SAMHSA does not have the authority to implement regulations that override the U.S. Code and legislation passed by Congress and signed by the President. Only Congress and the President can change legislative requirements enshrined in the U.S. Code. SAMHSA, as an Executive Branch agency, does not have the Constitutional authority to implement changes in 42 CFR Part 2 that override or otherwise attempt to invalidate core requirements and provisions of 42 USC 290dd-2.

In context of pervasive stigma and criminalization, patients need MORE privacy protections for people who use drugs, not less. Better integration between behavioral, mental, and other health info is necessary to improve care. Giving up privacy to get there is not a necessary trade-off.

The PDMP provision is a MAJOR fundamental change that threatens the essential framework of 42 CFR Part 2 and likely would result in unconstitutional executive overreach by SAMHSA that would override consent requirements required by 42 USC 290dd-2.

When an individual seeks treatment, they are acknowledging highly stigmatized and criminalized behavior. Drug use is subject to enormous negative consequences, including criminal liability, parental rights, housing, life insurance and other benefits. Confidentiality currently afforded by 42 CFR Part 2 protects patients from this discrimination.

The major function of Part 2 is to create relatively high bar on data access for law enforcement to assuage patient concerns about surveillance and their information being used against them. HIPAA provides no patient protection against law enforcement access of SUD treatment records.

What Should You Do?
What to Expect

This is called a New Proposed Rule Making (NPRM). The agency that oversees the regulations begins by posting a Comment Period.  Usually it is 90 days to give everyone the opportunity to write their comments.  SAMHSA only gave 30 days for Regulatory Information Number 0930-AA30 and 60 days for Regulatory Information Number 0930-AA32. The standard has always been a 90 day public commenting period, especially when there are significant changes.

Links to the pdf file proposing the NPRMs is at the beginning and comments can be submitted there.

Everyone that is a patient or an advocate for patients should comment. You can copy from this Press Release or write your own. And your comment can be as simple as:

“I am a patient (or advocate for patients) and this NPRM should not be implemented. Patients in Part 2 programs have been promised that their information is protected. What will they be told if these changes are made?  These changes are significant enough to make any therapeutic alliance between patients and Part 2 programs difficult.

Patients need MORE protection.

Signed Your Name”

Additional support around commenting with a direct hyperlink to the commenting website, as well as specifics between the two NRPMs, can be found here: 

If you are concerned about signing your name you could write, “I am afraid to sign my name because of the discrimination I’ve experienced.”


More Information:



SAMHSA Ushers in Law Enforcement “Fishing Expeditions” for MAT Patients


The Fundamentals of Part 2 (Legal Action Center)

SAMHSA to Propose Changes to 42 CFR Part 2

Fight for Patient’s Rights - Dr. Westley Clark, MD, JD, MPH and Danielle Tarino, MA


FLYER

CALL TO ACTION

Leave Comment on 
SAMHSA’s Confidentiality Proposals

The federal confidentiality law and regulations protect the privacy of substance use disorder (SUD) patient records by prohibiting unauthorized disclosures of patient records except in limited circumstances. Congress enacted the legislation in the 1970s to encourage individuals with SUDs to enter and remain in treatment. 42 USC § 290dd-2 is the law. The regulations implementing the law are at 42 CFR (Code of FederalRegulations) Part 2 and are commonly referred to as “Part 2.” Core protections against law enforcement and re-disclosure are just as critical today as they were in the 1970s.

PART 2 is UNDER ATTACK. The Trump Administration’s HHS Secretary Alex Azar and Assistant Secretary for Mental Health and Substance Use Elinore McCanze-Katz are overseeing two separate “Notices of Proposed Rule Making” (NPRM) that seek to obliterate the core confidentiality protections of Part 2. This one pager contains core concerns around each NPRM with a direct link to leave Public Comment.

NPRM #1: Proposal 0930-AA30                              COMMENTS DUE by 9/25/19 at 5pm Eastern!
  • Would allow personal health information to be shared outside the healthcare system for criminal justice purposes & allow law enforcement “fishing expeditions” in patient records to prosecute individuals enrolled in treatment or use patient records to prosecute others;
  • This proposed change is not in line with the best interests of patients seeking treatment for substance use disorders, and it goes against the fundamental reason for 42 CFR Part2;
  • These changes will deter people from seeking care out of fear of law enforcement involvement & encourage those enrolled in treatment to leave prematurely;
  • It has never been intended in any iteration of Part 2 that SUD treatment records be used in cases of "drug trafficking" against a patient, or another person. SAMHSA should not implement these proposed changes that have the potential to worsen the opioid crisis & deter individuals with OUD from seeking treatment.



NPRM #2: Proposal 0930-AA32                             COMMENTS DUE by 10/25/19 at 5pm Eastern!
  • Applicability and Re-Disclosure: Patient’s records in non-part 2 providers both previous and current are no longer covered. This is unacceptable, as re-disclosure protections are critical to the core confidentiality protections and purposes of Part 2.
  • Disclosures to Central Registries and PDMPs: This is one of the most frightening proposals that would obliterate the consent requirement of 42 USC 290dd-2 and allow any individual with a login to the Prescription Drug Monitoring Program (PDMP) to access information regarding an individual’s SUD treatment without their consent. NO SUD treatment information, including SUD treatment medications, should be uploaded into the PDMP. Law enforcement routinely accesses PDMPs in many states. This issue should not be “kicked” to the states, as core civil rights should always be protected federally.
  • Undercover Agents and Informants: Court-ordered placement of an undercover agent or informant within a Part 2 program will be allowed for a period of 12 months. There is no place for informants in SUD treatment programs. Allowing this will frighten prospective & current patients from treatment during a time of crisis and will obliterate the confidentiality protections required by 42 USC 290dd-2.





No comments: