When the U.S. House of Representatives passed H.R. 6082 last June methadone patients worried that they would lose their confidentiality. The bill would remove a major portion of the protections of 42 CFR Part 2, the regulation requiring most substance use disorder (SUD) treatment providers to obtain patient consent before releasing their records, by allowing disclosures without patient consent for purposes of treatment, payment and health operations. See related article in this issue (Opioid Bills in the Senate: Focus on Medicare and OTPs originally released August 14, 2018).
The bill is now in the Senate Committee on Health, Education, Labor, and Pensions. For almost 10 years, opponents of CFR Part 2–electronic health record (EHR) vendors, at first–have desperately wanted SUD treatment records, including those about methadone treatment, to be in the patient’s electronic records.
Now, most treatment organizations, including the National Association of Addiction Treatment Providers and the American Society of Addiction Medicine, have joined in wanting to eliminate 42 CFR Part 2. So has the American Psychiatric Association. But the American Association for the Treatment of Opioid Dependence (AATOD), Faces and Voices of Recovery, and the Legal Action Center have steadfastly supported keeping the regulation.
Interestingly, some of the largest Opioid Treatment Program (OTP) chains have allied themselves with the anti-42 CFR Part 2 forces. This places the clinical operators of those OTPs at odds with the policy of the corporations that own them. The question of why companies would support something that would likely deter patients from seeking or staying in treatment is still not answered.
Revised Rule by SAMHSA
Last year, when the Substance Abuse and Mental Health Services Administration (SAMHSA) issued its final rule on the regulation, confidentiality protections were kept, but many changes were made that were hoped to assuage opponents (see http://staging3.atforum.com/2017/02/final-rule-42-cfr-part-2-retains-core-confidentiality-protections/). However, the agency couldn’t go any farther than that, leaving Congress to take up the matter.
The core protections are retained: that patients must consent to the release of their information, and that redisclosure is not permitted. This means that when the patient consents to having information released to a specified individual, the individual receiving the information may not redisclose it to a third party.
The rule requires that consent be given to a “specific name,” but the patient can agree to a “general designation” instead, which allows for the flexibility many people had wanted. But it still gives the patient the choice.
“I have always been concerned about the patient’s response, which is why we have advocated against this for such a long time,” said Mark W. Parrino, MPA, president of AATOD. “As you know, this has to go to the Senate and this will be our last bastion of defense,” he added. “Given the majority vote in the House, I cannot claim to be hopeful.”
“We don’t have any idea either how many patients are feeling the stress, but also are hearing stories that people are scared, and understandably so,” said Paul Samuels, president of the Legal Action Center, which has been advocating to save 42 CFR Part 2. Asked whether OTPs would be required to divulge patient information if the regulation changes, Mr. Samuels said, “We haven’t thought down the road here about what might happen in terms of the mechanics of this, in part because this is still in process.” The best-case scenario would be for the Senate version not to pass, he said. “This is a moving target which we’re still hoping we’ll be able to stop.”
The main message, Mr. Samuels said, is this: “In the middle of the nation’s worst opioid epidemic, we should be encouraging everyone to stay in treatment.” Mr. Samuels urges everyone who is concerned about patient privacy to contact their senators. And he urges patients not to taper. “Don’t get scared, don’t stop your lifesaving treatment; use your constitutional rights,” he said. “Members of Congress always pay attention to the phone calls and mail.”
Lawsuits by Patients
Westley Clark, MD, JD, Dean’s Professor at Santa Clara University, and former director of SAMHSA’s Center for Substance Abuse Treatment, said that treatment providers should not be surprised if the elimination of 42 CFR Part 2 comes back to hurt them. Patients whose confidentiality is breached will most likely sue for harms such as loss of custody, loss of a job, and all the problems that can happen when someone’s status as a methadone patient is revealed.
If the bill gets through the Senate, said Dr. Clark, “it won’t be long before the first lawsuits are filed against SUD treatment programs for reckless behavior in disclosing SUD treatment–derived information that winds up prejudicial to a person who sought treatment,” he said. “Then the SUD providers will begin to understand what they’ve gotten themselves into for the weak promise of integrated care.”
“In addition, since HR 6082 permits the reporting of de-identified patient information to public health authorities without providing for who is going to pay for this capability,” said Dr. Clark. “State authorities could reasonably shift the cost to treatment programs by imposing new requirements for EHR as a part of SUD treatment program licensing,” he said, adding “this would force treatment programs to increase their costs in the middle of an opioid epidemic.”
Meanwhile, methadone patients are at risk. When they taper, they may relapse, and overdose, and die.
Costs to Programs
Eliminating 42 CFR Part 2 will also result in increased costs to OTPs, increased training requirements, and an increased risk for inadvertent disclosure, said Dr. Clark. “This isn’t simply about patients giving permission,” he said. “It is also about a more aggressive training program for staff. Given staff turnover in clinics, the possibility of errors goes up.”
For example, staff will have to be able to distinguish between self-pay patients and other patients, he said. Even H.R. 6082 recognizes this, when it states that the bill offers patients a “statement of the patient’s rights, including self-pay patients, with respect to protected health information and a brief description of how the individual may exercise these rights (as required by paragraph (b)I1)(iv) of such section 164.520.”
Support from TCA and NAADAC
Treatment Communities of America (TCA) and NAADAC, the Association for Addiction Professionals also oppose H.R. 6082 and changes to 42 CFR Part 2. “The bill represents a step back from the protections that patients in this very vulnerable population currently possess, and we believe the risks and harm that can be done to patients is greater than the purported benefits that would be gained were the bill to become law,” wrote Kathy Icenhower, PhD, president of TCA, in letters to Senate leadership July 2.
“Stigma related to addiction historically has been one of the most formidable hurdles to people with SUD seeking treatment, including the very real fear of negative consequences, and people with SUD understand how essential confidentiality and privacy are as they embark on a courageous journey into treatment and recovery,” she added.
“According to SAMHSA, there are profound negative consequences that can result from the disclosure of an individual’s substance use disorder treatment record, including loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. That is why provisions in H.R. 6082 that would eliminate a SUD patient’s current legal right and ability to consent to disclose their treatment information for ‘treatment, payment, and health care operations’ purposes is so concerning. Under the bill, this sensitive information would be allowed to be disclosed to and shared with health plans, health care providers, and other entities without the patient’s knowledge and consent. This is a tremendous reversal and erosion of the protections that SUD patients currently possess, and has the potential to do tremendous harm in the midst of an opioid epidemic already claiming the lives of over 50,000 Americans each year.”
You can sign a petition to support 42 CFR Part 2 and oppose H.R. 6082. Go to https://t.e2ma.net/webview/pq9oq/c2e88ffd677340796cee4f151e6427c8
Note: The original article AT Forum wrote about current pending legislation can be accessed at: http://staging3.atforum.com/2018/08/opioid-bills-senate-focus-medicare-otps/