Notice Of Proposed Rulemaking Research Articles

DEA proposes limits on telehealth for buprenorphine

The public health emergency for COVID‐19 will end in May, and with it all of the exemptions for methadone and buprenorphine. This is partly why the NPRM (Notice of Proposed Rulemaking) for methadone (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33643) came out when it did, codifying many of the flexibilities for methadone that were in the public health emergency and adding to them. A big focus of these flexibilities is on telehealth. It's also why the Drug Enforcement Administration (DEA) issued its proposed rules this month.

AATOD comments on Part 8 NPRM

The Notice of Proposed Rulemaking (NPRM) issued in December (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33643) that liberalized many of the federal rules governing opioid treatment programs (OTPs) — the only treatment provider allowed to treat opioid use disorder (OUD) with methadone — has drawn key comments from the field. This NPRM concerned Part 8 of 42 CFR Part 2. Don't confuse it with the NPRM also in process concerning Part 2 (confidentiality of substance use disorder treatment records), which ADAW has covered as well (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33661). We have been publishing selected comments to both NPRMs out of concern that they be included in the public record, as previously the federal government in summaries has cherry‐picked comments supportive of its proposals (https://onlinelibrary.wiley.com/doi/10.1002/adaw.32640).

NAMA comments on Part 8 NPRM to revise methadone treatment regulations

In December, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice of proposed rulemaking (NPRM) that would make permanent the take‐home exemptions for methadone under which, due to COVID‐19, it was possible for “less stable” patients to receive more take‐homes (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33643). In addition, the proposal would remove the one‐year requirement for opioid use disorder (OUD), remove the reliance on toxicology tests and the length of time in treatment, and allow telehealth inductions by methadone.

Comment on Part 2 NPRM: Concerns from addiction psychiatrist

At the end of last month, when the comment period closed for the Notice of Proposed Rulemaking (NPRM) on the Confidentiality of Substance Use Disorder (SUD) Patient Records (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33628), ADAW started obtaining some of the comments that were filed. We are printing some of them here, as the last time there was a big NPRM on this rule, the Substance Abuse and Mental Health Services Administration (SAMHSA) was highly selective in its summary of the comments, leaving out some of the most poignant and articulate concerns and focusing on ones that supported its proposal to weaken the rule.

Recovery organization PRO‐A comments on Part 2 NPRM

The U.S. Department of Health and Human Services (HHS) has proposed significant changes to 42 CFR Part 2, known as Part 2, in a Notice of Proposed Rulemaking (NPRM) issued last year (see https://onlinelibrary.wiley.com/doi/10.1002/adaw.33678, https://onlinelibrary.wiley.com/doi/10.1002/adaw.33661, https://onlinelibrary.wiley.com/doi/10.1002/adaw.33637, https://onlinelibrary.wiley.com/doi/10.1002/adaw.33628).

Senator Joe Manchin's Useful, but Stalled, Interstate Energy Permitting Reform

West Virginia Senator Joe Manchin spent much of 2022 pursuing an energy siting and permitting reform bill—“Building America's Energy Security Act of 2022”—that aimed to accelerate permitting of all types of American energy infrastructure to promote energy security and climate objectives, without bypassing environmental laws or state and local input. At the same time, 2022 saw actions by the Federal Energy Regulatory Commission (FERC), in the form of Notices of Proposed Rulemaking (NOPRs), that muddied permitting for both useful natural gas pipelines and electricity transmission projects in different ways, as I previously wrote about in this column in July and September, 2022. Manchin was not successful in inserting his permitting reform bill into President Biden's $1.7 trillion federal spending bill signed on December 29, 2022. But as Chairman of the Senate Energy and Natural Resources Committee, he expressed his displeasure with FERC—effectively sacking then FERC Chair Richard Glick by failing to hold a hearing on his nomination by President Biden for a second term.

Confidentiality revamping proposed for substance use disorder treatment records

Parents want the privacy of their children, including their young adult children, protected. This includes treatment records for addiction. But bit by bit, the confidentiality protections of these records are being eroded. Late last year, the Department of Health and Human Services (HHS) published a 260‐page Notice of Proposed Rulemaking (NPRM) on changes to 42 CFR Part 2, a regulation which protects the confidentiality of treatment records for alcohol and drug use disorders.

AATOD's Parrino focusing on the star: Part 8 NPRM

With all of the buzz swirling about buprenorphine — the victory of eliminating the X‐waiver claimed by Congress, the White House, the American Society of Addiction Medicine, the U.S. Department of Health and Human Services, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Drug Enforcement Administration, and on and on — what is the main organization dedicated to the treatment of opioid use disorder (OUD) with methadone (and buprenorphine), i.e., the American Association for the Treatment of Opioid Dependence (AATOD), up to? AATOD is looking carefully at, and responding to, the Part 8 Notice of Proposed Rulemaking (NPRM), which makes methadone treatment much more accessible and flexible than it was.

Part 2 NPRM deadline for comments: Jan. 31

This month, ADAW attended a webinar by the Legal Action Center on the Notice of Proposed Rulemaking (NPRM) for 42 CFR Part 2. Comments are due Jan. 31. To submit them, go online to the federal Regulations.gov website and its “Remember that comments are due January 31, 2023,” page, and comments can be submitted here: https://www.regulations.gov/commenton/HHS‐OCR‐2022‐0018‐0001

Confidentiality revamping proposed for substance use disorder treatment records

Late last year, the Department of Health and Humans Services (HHS) published a 260‐page Notice of Proposed Rulemaking (NPRM) on changes to 42 CFR Part 2, a regulation which protects the confidentiality of treatment records for alcohol and drug use disorders.

SAMHSA proposes reforms to methadone rules, keeps OTPs in charge

Last week, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice of proposed rulemaking (NPRM) that would make permanent the take‐home exemptions of COVID‐19, making it possible for “less stable” patients to receive more take‐homes. In addition, the proposal would remove the one‐year requirement for opioid use disorder (OUD), remove the reliance on toxicology tests and the length of time in treatment and allow telehealth inductions by methadone.

Part 2 update: NPRM raises many concerns

Last week, the Department of Health and Human Services (HHS) released its plan for revamping 42 CFR Part 2, the confidentiality regulation protecting alcohol and drug use treatment records (see “HHS issues NPRM on 42 CFR Part 2,” ADAW, Dec. 5; https://onlinelibrary.wiley.com/doi/full/10.1002/adaw.33628). The HHS Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration issued the Notice of Proposed Rulemaking (NPRM) officially last week; we covered it based on the draft. There were no significant changes between the draft and the final. Both significantly weaken privacy protections.

How 42 CFR Part 2 changes affect OTPs – methadone and PDMPs

H. Westley Clark, M.D., J.D., is the former director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency that has proposed to amend 42 CFR Part 2, the regulation protecting the confidentiality of alcohol and drug abuse treatment patient records. In a massive notice of proposed rulemaking (NPRM) published in 2019, SAMHSA proposed to remove the ban against giving opioid treatment program (OTP) patient data — methadone being the key medication — to prescription drug monitoring programs (PDMPs). That ban was instituted by Clark himself when, as CSAT director, he issued a “Dear Colleague Letter” to OTPs telling them they should not give patient medication data to the PDMP, but rather should check the PDMP to see what medications their patients are on. The rationale for the letter was the same as the rationale for opposition to SAMHSA's NPRM: Patients would not want to go to treatment if they knew their methadone information could be shared without their consent.

Where's the Transmission?

The Federal Energy Regulatory Commission (FERC) recently released two Notices of Proposed Rulemaking (NOPR), on April 21 and June 16, 2022, on national electricity transmission and related matters. The NOPRs ostensibly deal with the issues that I wrote about in March 2022 regarding the failures of US policy makers to identify the unique geographic problems of what I label “Transmission III.” However, the NOPRs are immensely frustrating documents, both in their form and in their thin—and essentially retrograde—substance in the context of the largest problem facing US electricity transmission today: the failure to define a pathway for speeding the entry of renewable electricity generation on to the larger US transmission grid.

HHS proceeds with weakening of HIPAA, including for SUD

The federal Department of Health and Human Services (HHS), which under former President Donald Trump threatened to open up patient record protections under the Health Insurance Portability and Accountability Act (HIPAA; see “In case you haven't heard,” ADAW, Jan. 11, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32940), has made good on its threat. The HHS Office for Civil Rights (OCR) published its notice of proposed rulemaking (NPRM), the “Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule),” in the Jan. 21 Federal Register — a day after President Joe Biden was inaugurated (and a day after the new administration placed a freeze on rulemakings).

Why the vision of interregional electric transmission development in FERC Order 1000 is not happening

The Federal Energy Regulatory Commission (FERC) on March 19, 2020 announced a Notice of Proposed Rulemaking (NOPR)iiFERC Docket RM20-10-000. to further investigate how financial incentives might be used to encourage development of high-voltage electric transmission in the United States. An extension of previous efforts in FERC Order 679 issued in 2006, the NOPR-proposed incentives would consist of up to 250 additional basis points of equity return to be allowed on qualifying transmission projects. The NOPR was published in the Federal Register on April 2, and public comments were due back to FERC by July 1.Such incentives, if adopted, would be helpful to address prior FERC business that is yet undone. Issued in 2011, FERC Order 1000, “Transmission and Cost Allocation by Transmission Owning and Operating Utilities” among other things envisioned coordinated planning of interregional transmission developments spanning between individual Regional Transmission Organizations (RTO) and Independent System Operators (ISO), the operators of the FERC-regulated organized wholesale markets. In addition to traditional goals of generator interconnection and service reliability, the purpose of such interregional transmission development was to support public policy goals including renewable energy development, and lower costs for consumers.But little or no such interregional development has happened since Order 1000. Why? The authors have spent the last several years promoting development of one such interregional transmission project. While the effort is ongoing, the on-the-ground experience to-date clearly shows the reasons why interregional development envisioned by FERC Order 1000 is not happening. The authors offer solutions to the issues, including how the new FERC NOPR for transmission incentives can be helpful.

Cover‐up: No patient voices in SAMHSA ‘summary’ of 42 CFR Part 2 NPRM

Leaving out the organizations that opposed the federal government's proposal to eliminate the confidentiality protections of 42 CFR Part 2, MITRE, the company contracted to create a “summary” of public comments, has produced a slideshow that relies on two dozen “prominent” organizations. These organizations exclude those that oppose the changes in the Notice of Proposed Rulemaking (NPRM) released by the Substance Abuse and Mental Health Services Administration (SAMHSA) on Aug. 26, 2019 (see “SAMHSA proposes significant changes to 42 CFR Part 2,” ADAW, Sept. 9, 2019, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32473).

Estimating the Costs and Benefits of Fuel-Economy Standards

Fuel-economy standards for new vehicles are a primary policy instrument in many countries to reduce the carbon footprint of the transportation sector. These standards have many channels of costs and benefit, impacting sales, composition, vehicle attributes, miles traveled and externalities in the new-car fleet, as well as the composition and size of the used fleet. We develop a tractable analytical framework to examine the welfare effects of fuel-economy standards, and apply it to the recent government proposal to roll back fuel-economy standards. We find that our combined, multi-market vehicle choice model implies that the proposal would increase the size of the vehicle fleet over time, and also generates smaller welfare gains than models with a less rich structure of the vehicle market, such as the one used in the analysis associated with the 2018 Notice of Proposed Rulemaking (NPRM) announcement. The disparities across the two models appear to result from the absence of feedback effects in the NPRM analysis. We stress the importance of instead using a multi-market vehicle choice model to provide the most accurate predictions of costs and benefits. We also derive bounds that can serve as a check on the theoretical consistency of such analyses, and that other insights into the magnitudes of potential errors resulting from imperfect multi-market integration.

Survey of Spectrum Regulation for Intelligent Transportation Systems

As 5G communication technology develops, vehicular communications that require high reliability, low latency, and massive connectivity are drawing increasing interest from those in academia and industry. Due to these developing technologies, vehicular communication is not limited to vehicle components in the forms of Vehicle-to-Vehicle (V2V) or Vehicle-to-Infrastructure (V2I) networks, but has also been extended to connect with others, such as pedestrians and cellular users. Dedicated Short-Range Communications (DSRC) is the conventional vehicular communication standard for Intelligent Transportation Systems (ITS). More recently, the 3 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">rd</sup> Generation Partnership Project introduced Cellular-Vehicle-to-Everything (C-V2X), a competitor to DSRC. Meanwhile, the Federal Communications Commission (FCC) issued a Notice of Proposed Rulemaking (NPRM) to consider deploying Unlicensed National Information Infrastructure (U-NII) devices in the ITS band with two interference mitigation approaches: Detect-and-Vacate (DAV) and Re-channelization (Re-CH). With multiple standard options and interference mitigation approaches, numerous regulatory taxonomies can be identified and notification of relevant technical challenges issued. However, these challenges are much broader than the current and future regulatory taxonomies pursued by the different countries involved. Because their plans differ, the technical and regulatory challenges vary. This article presents a literature survey about the technical challenges, the current and future ITS band usage plans, and the major research testbeds for the U.S., Europe, China, Korea, and Japan. This survey shows that the most likely deployment taxonomies are (1) DSRC, C-V2X, and Wi-Fi with Re-CH; (2) DSRC and C-V2X with interoperation, and (3) C-V2X only. The most difficult technical challenge is the interoperability between the Wi-Fi-like DSRC and 4G LTE-like C-V2X.

Former CSAT director to SAMHSA: Withdraw 42 CFR Part 2 proposal

H. Westley Clark, M.D., J.D., is the former director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency that has proposed to amend 42 CFR Part 2, the regulation protecting the confidentiality of alcohol and drug abuse treatment patient records. In a massive notice of proposed rulemaking (NPRM) published Aug. 26 (see ADAW, Sept. 9), SAMHSA proposed to remove the ban against giving opioid treatment program (OTP) patient data — methadone being the key medication — to prescription drug monitoring programs (PDMPs). That ban was instituted by Clark himself when, as CSAT director, he issued a “Dear Colleague Letter” to OTPs telling them they should not give patient medication data to the PDMP, but rather should check the PDMP to see what medications their patients are on. The rationale for the letter was the same as the rationale for opposition to SAMHSA's NPRM: Patients would not want to go to treatment if they knew their methadone information could be shared without their consent.