The Trump administration plans to change how patients who are treated for substance use must give consent to have their medical records shared with hospitals or pain doctors, according to two sources briefed on the discussions.
The change is under way because the current burdensome consent requirements create an easy way for other doctors to unwittingly prescribe opioids and get the patients hooked again.
The Department of Health and Human Services is planning to release a proposed rule in August to change a regulation that specifically governs privacy for patients who undergo substance use treatment. The law is designed to protect these patients from stigmatization or retaliation by giving them control over who can see their medical records. It only governs substance-use records and prevents law enforcement from using patients’ records against them.
Substance-use patients must give affirmative consent for their records to be shared with any other doctor for treatment, payment, or health-care operations. If they agree to that, they then must give consent each time the record is shared with a doctor outside the health system that originally treated them for substance use. This includes general primary care and pain management doctors.
The process is unlike the general health privacy law, under which doctors are required to inform patients that their records may be shared with other health providers. But doctors don’t need the patient’s consent to share records.
The substance use law, as enacted in 1974, only required an initial patient consent for record sharing, but subsequent regulatory changes led to a requirement for multiple consents, Duanne Pearson, senior director of federal affairs at hospital purchasing alliance Premier Inc., said. Pearson is the lead lobbyist on the issue and is in close contact with the HHS on the drafting of the rule.
The administration has several options to simplify the rule, including requiring patients to only consent once for their records to be shared with all of their doctors, Pearson said.
Patients who are treated for other conditions are asked to sign a form that says they understand their records may be shared under the Health Insurance Portability and Accountability Act, or HIPAA.
The substance use treatment form is longer and more complicated because the regulation is so complex, Pearson said. That could cause problems for substance use patients who may have cognitive difficulties. The administration could simplify that form as part of the change. It could also attach a general HIPAA form to the substance abuse consent form.
The administration will argue that it has the authority to make the change without consulting Congress because the current process came about under HHS rules, the sources said.
The proposed rule is undergoing review at the Office of Management and Budget.
The HHS had initially planned to issue a request to the health community on what sort of changes should be made. Administration officials decided against that because they now understand the issue well enough after receiving some public input on it, one source said.
The agency has already received recommendations on how to improve the substance use disclosure rule through public comment on two separate rules in the works that will make changes to HIPAA and facilitate the electronic exchange of records.
Uneven Paperwork Burden
The rules around substance-use records only apply to health providers who receive federal funding for treatment programs, including Medicare and Medicaid. People who are treated for substance use through private insurance must only sign the form saying they understand their rights under HIPAA, creating an uneven paperwork burden for patients using Medicare and Medicaid, Pearson said.
Having these different standards can result in decreased care coordination between providers and could lead to instances where a doctor writes a prescription for opioids without knowing a patient has a substance use disorder, Kate Romanow, director of regulatory affairs at the Association for Behavioral Health and Wellness, said.
Congress attempted to pass a bill streamlining the substance-use consent requirements in 2018, but there was a disagreement between House members and Senate Democrats about whether the patient needs to give consent at all.
The bill (H.R. 6082) that passed the House would have allowed doctors to disclose information about a patient’s substance use treatment without their consent as long as they complied with the general health privacy law. The bill was ultimately left out of a package of dozens of bills to combat the opioid crisis that was signed into law in late 2018.
Substance-use records are the only health records that are separated from the rest of a patient’s file, Romanow said. These separations can lead to health inequities between patients, especially for those on Medicare and Medicaid.
Concerns From Advocates
However, privacy advocates and attorneys fighting discrimination are concerned that aligning the substance-use record law with HIPAA could hurt patients.
Twila Brase, president of the Citizens’ Council for Health Freedom, says that the protections under the substance-use record law should be extended to all patients for all conditions. In her view, HIPAA takes away privacy and consent rights because it allows doctors to access all of the records of any patient they have treated. The information could also be sold to for-profit companies with only the patient name removed, she added.
Easing the consent requirements could also cause people to shy away from treatment. The substance-use record law provides “sufficient confidentiality for people with substance-use disorders, so that not only will their privacy will be protected, but that people will feel comfortable to come in and get treatment,” Paul Samuels, president and director of the nonprofit Legal Action Center, said.
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(In 14th paragraph, corrects which health providers the rules around substance-use records apply to. )