Modernizing Healthcare Legislation in the Face of the Opioid Crisis

Health Care Law Practice Group

By Health Care Law Practice Group

opioid crisis

In 2016, opioid overdoses accounted for more than 42,000 deaths in America. It was estimated that 11.5 million people misused opioid prescriptions and 2.1 million people suffered from an opioid use disorder that same year.[1] From July 2016 to September 2017, the Center for Disease and Prevention found that opioid overdoses increased 30% in 45 states; however, the Midwest region alone saw a 70% increase.[2] On October 26, 2017, President Trump declared the opioid crisis a national Public Health Emergency under federal law.

While the federal government has responded by allotting six billion dollars to assist in the treatment and prevention of opioid overdoses, hospitals and medical providers still face barriers when it comes to the disclosure of medical information related to these overdoses due to conflicts between HIPAA and other federal law. Congress is working to resolve this conflict.

In 2017, the Department of Health and Human Services Office for Civil Rights (OCR) released a new HIPAA Guidance on when and how healthcare providers may share a patient’s health information with his or her family members, friends, and legal representative if the patient is in crisis. Current HIPAA regulations permit (but do not require) healthcare professionals to disclose health information without a patient’s consent if the provider determines that doing so is in the best interest of an incapacitated or unconscious patient and the information shared is directly related to the family or friend’s involvement in the patient’s healthcare or payment of care. This allows a provider to talk to the parents of someone incapacitated by an opioid overdose about the overdose, but generally does not allow disclosure of medical information unrelated to the overdose without the patient’s permission.

HIPAA also allows the disclosure of relevant medical information to individuals in a position to prevent or lessen a serious or imminent threat to a patient’s health or safety. A doctor may then disclose the opioid abuse to family, friends, or caregivers involved in the patient’s care, if the patient poses a serious threat to his or her health through continued opioid abuse upon discharge. This disclosure is allowed even if the patient objects.

While the Guidance has alleviated some of the restraints on providers, conflicts remain with 42 CFR Part 2, which currently restricts the disclosure of patient records concerning addiction treatment by any federally assisted alcohol and drug abuse program without the express written consent of the patient. This means that mental health records kept separately from other health records prevent treating providers from seeing the entire medical record of a patient with an addiction unless the patient gives written consent. As a result, a patient may be prescribed an opioid to treat pain without the provider knowing that the patient has a history of addiction.

Both the House and Senate are now pushing for legislation that aligns 42 CFR Part 2 with the HIPAA Privacy Rule.

The House recently passed the Overdose and Prevention and Patient Safety Act (H.R.6082) which authorizes the disclosure of substance use disorder (SUD) patient records without the patient’s written consent to: (1) a covered entity for the purposes of treatment, payment, and health care operations, so long as the disclosure is made in accordance with HIPAA; and (2) a public health authority, as long as the content of the disclosure meets HIPAA standards. This bill would update 42 CFR Part 2 to more effectively handle the opioid crisis so that all health providers may better assess risks and adequately care for their patients.

Opponents are worried the bill will allow medical information to be acquired by police or the patient’s employer. However, the bill provides safeguards to prevent the mistreatment of the patient’s medical information by prohibiting the use of such records in any criminal, civil, or administrative investigations, actions, or proceedings, except with an authorization from the patient or by court order. In addition, the bill prohibits discrimination based on data disclosed from these records. The bill is now awaiting Senate vote, however, currently there is only a 35% chance of passage, according to Congressional bill tracking.[3]

The Senate has also separately made an effort to relieve 42 CFR Part 2’s stringent measures with the Opioid Crisis Response Act of 2018 (S.2680). This bill would help healthcare providers obtain information about a patient’s history of opioid abuse to improve healthcare treatment and prevent prescribing opioids to addicts. The bill calls for identifying model training programs to learn how to appropriately disclose confidential SUD medical records to healthcare providers, patients, and their families. Some are worried that this bill would not completely remove 42 CFR Part 2’s restrictions faced by providers. This bill has a predicted 79% chance of passing both the Senate and House.[4]

As of now, 42 CFR Part 2 governs disclosure of SUD information. However, with the House and Senate’s efforts to modernize the law in the face of the opioid crisis, stay tuned to future changes to the HIPAA Privacy Rule.

[1] https://www.hhs.gov/opioids/about-the-epidemic/index.html

[2] https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis#ten

[3] https://www.govtrack.us/congress/bills/115/hr6082

[4] https://www.govtrack.us/congress/bills/115/s2680

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