As HIPAA changes loom,patients demand continued confidentiality for SUD records

In last week's issue, we wrote about the plans by the federal Department of Health and Human Services (HHS) to weaken the Health Insurance Portability and Accountability Act (HIPAA), citing regulatory burdens and the need for information‐sharing (see ADAW, Jan. 21). The plans, detailed in a request for information (RFI) issued Dec. 12, throw a wrench into the plans by the “make 42 CFR Part 2 like HIPAA” movement, which would erase the federal confidentiality regulation protecting substance use disorder (SUD) treatment records by watering it down to HIPAA standards. Now, with even HIPAA seeming too burdensome, the need is even greater to protect the consent provision of 42 CFR Part 2 — which is basically all that's left after the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed information‐sharing for the vague “health care operations” without consent last year (see ADAW, Jan. 8, 2018). Last week, H. Westley Clark, M.D., J.D., dean's executive professor at Santa Clara University and former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, made this abundantly clear in his comments to ADAW.     

42 CFR Part 2 now up for SAMHSA rulemaking change

After complaining about 42 CFR Part 2, the regulation requiring patients to consent to release of their substance use disorder (SUD) treatment records, for years, but saying that Congress had to fix it, the Substance Abuse and Mental Health Services Administration (SAMHSA) is on the brink of changing the regulation.     

SAMHSA proposes significant changes to 42 CFR Part 2

In two separate proposals, the Substance Abuse and Mental Health Services Administration (SAMHSA) last month proposed radical changes to the confidentiality of substance use disorder (SUD) treatment records under 42 CFR Part 2. Both were in a Notice of Proposed Rulemaking (NPRM) and were published in the Federal Register Aug. 26.     

What happened in 2018: Funding and more funding

2018 saw continued funding for the opioid crisis, mainly in the form of grants from the Substance Abuse and Mental Health Services Administration (SAMHSA). There was also an upswing in interest in harm reduction. Opioids, as in past years, led the news. Finally, the move to get rid of the confidentiality regulation (42 CFR Part 2) got stronger than ever. What follows is a brief summary of some of the many stories that ran in our 48 issues last year.     

SAMHSA refers to streamlining in proposed budget cuts

Last week, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its Congressional Justification (CJ), issued by agencies in conjunction with the White House budget request for the next fiscal year. For FY 2020, the White House budget did not request additional money for SAMHSA's Substance Abuse Prevention and Treatment (SAPT) block grant, and included cuts to substance abuse prevention (see ADAW, March 18).     

AMA and ASAM have different views on SAMHSA NPRM

The comment period for the notice of proposed rulemaking (NPRM) that would allow law enforcement to have access to all patient records if it is investigating an alleged serious crime by a patient (see ADAW, Sept. 9) closed Sept. 25. There was no extension, as some (including the American Medical Association [AMA]) had requested (see ADAW, Sept. 23). This proposal, by the Substance Abuse and Mental Health Services Administration (SAMHSA), would alter 42 CFR Part 2 by allowing this access, also changing the definition of serious crime to include anything related to drug trafficking.     

Senators call for $2 billion in supplemental SAMHSA funding

As the fourth stimulus bill, the HEROES Act, awaits action by the Senate, 19 senators sent a letter last week to Senate and House leadership calling for increased investments in substance use disorder programs during the COVID‐19 pandemic. The letter, from Senators Tammy Baldwin (D‐Wisconsin) and Jeanne Shaheen (D‐New Hampshire), along with 17 other senators (all Democrats), calls for “$2 billion in funding for the Substance Abuse and Mental Health Services Administration (SAMHSA) to administer supplemental grant allocations under the Substance Abuse Prevention and Treatment (SAPT) Block Grant program and the State Opioid Response (SOR) grant program.”     

SAMHSA urges treatment programs to test for HIV

Last month, the federal Substance Abuse and Mental Health Services Administration (SAMHSA) called on public health and substance use disorder (SUD) treatment providers to help make sure patients who are negative for human immunodeficiency virus (HIV) stay that way, and that those who are HIV‐positive are tested, receive antiretroviral treatment and stay “adherent” to the treatment. The directive came in the form of a “Dear Colleague Letter” from SAMHSA Director Elinore F. McCance‐Katz, M.D., Ph.D., assistant secretary for mental health and substance use for the Department of Health and Human Services.     

President's proposed budget would slash treatment and prevention funding

We had a feeling of déjà vu when the White House sent its proposed budget to Congress last week. Similar to past years, the Office of National Drug Control Policy (ONDCP) would be decimated, moving the $100 million Drug‐Free Communities program to the Center for Substance Abuse Prevention (CSAP) at the Substance Abuse and Mental Health Services Administration (SAMHSA). There's no additional money in the Substance Abuse Prevention and Treatment (SAPT) block grant and cuts to the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, CSAP and SAMHSA's Center for Substance Abuse Treatment.     

White House budget request decimates substance use prevention

The White House budget request for fiscal year 2021 for the Substance Abuse and Mental Health Services Administration (SAMHSA) proposes to zero out a major prevention program — the Strategic Prevention Framework State Incentive Grant — Partnerships for Success program. This is a cut of $109 million. It recommends using the prevention set‐aside (20%) from the Substance Abuse Prevention and Treatment (SAPT) block grant instead. But it doesn't give any more money to the block grant.     

After 30 years,SAMHSA walks away from Recovery Month

“Recovery” is widely considered the main brand of the Substance Abuse and Mental Health Services Administration (SAMHSA), and every September for 30 years, recovery from addiction has been celebrated, with gradually increasing input from the recovery field. But communication, hasn't been SAMHSA's strong point, at least with the recovery community.     

Onslaught against 42 CFR Part 2 continues in Congress

With the opposition of the American Medical Association (AMA) last fall, any moves in Congress and the federal government to weaken the patient consent provisions of 42 CFR Part 2, the regulation protecting the confidentiality of substance use disorder (SUD) treatment records, were stopped in their tracks — and in the nick of time (see ADAW, Oct. 1, 2018; Oct. 15, 2018). But the groups promoting the complete abandonment of 42 CFR Part 2, replacing it with the Health Insurance Portability and Accountability Act, which itself is targeted for at least partial destruction (see ADAW, Jan. 21, Jan. 28, Feb. 25), are back. There's a new push to try to overhaul 42 CFR Part 2.     

SAMHSA to write new application for new SOR with stimulants included

The addition of stimulants as an allowable use for State Opioid Response (SOR) grants will require a new application, which the Substance Abuse and Mental Health Services Administration (SAMHSA) is working on, ADAW has learned. The change was in the FY 2020 appropriations bill passed last month by Congress (see ADAW, Dec. 23, 2019; “FY 2020 Appropriations: Stimulants added to SOR's $1.5 billion,” https://onlinelibrary.wiley.com/doi/10.1002/adaw.32573 ), along with funding for other SAMHSA programs, including the Substance Abuse Prevention and Treatment block grant (SAPT BG). After the bill passed before Christmas, Washington went away for the holidays.     

Text of opioid bill released by House Ways and Means Committee: 42 CFR Part 2 is spared

Last week, the long‐awaited opioid package was released by the House of Representatives Ways and Means Committee. Notably, 42 CFR Part 2, which the House version had slated for elimination but the Senate had not addressed, is spared. The confidentiality regulation, which requires substance use treatment providers to obtain consent from patients before releasing their information, would have been replaced with the Health Insurance Portability and Accountability Act (HIPAA), which would have included their information in their record.