ACAP Comments 42 CFR Part 2 SNPRM

February 17, 2017

Danielle Tarino
Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20852

RE: Comments on Confidentiality of Substance Use Disorder Patient Records Supplementary Notice of Proposed Rulemaking (SAMHSA-4162-20 RIN 0930-AA-21)

Dear Ms. Tarino:

The Association for Community Affiliated Plans (ACAP) is an association of 59 not-for-profit Safety Net Health Plans in 28 states that serve more than 17 million Americans in Medicaid, Medicare, the Children’s Health Insurance Program, and low-income persons receiving coverage through the health insurance Marketplaces. As you know, there is a much higher prevalence of people suffering from SUD within the Medicaid and low-income population than in the general population. As such, this issue is of particular importance to health plans and providers seeking to provide the most effective and efficient care to this high-need population. We appreciate this opportunity to comment on the supplementary notice of proposed rulemaking to 42 CFR Part 2 on the confidentiality of substance use disorder (SUD) patient records. Based on the preamble, it is our understanding that our comments to the February 9, 2016 NPRM will also be reconsidered as part of this effort. ACAP is appending those comments dated April 11, 2016 comments as part of this submission.

As noted in our earlier comments, States and the Federal government have turned to managed care organizations (MCOs) to provide coordinated, integrated care for people with Medicaid, Medicare, and CHIP coverage. These MCOs integrate care to assess member needs, identify treatment gaps, engage members, develop individualized care plans, and coordinate care. These programs are particularly important to facilitate physical and behavioral health care and social services for enrollees with SUD. ACAP strongly supports the privacy and confidentiality of members who live with a SUD.

While we support the changes that were made, the recently published revisions to the federal requirement for patient consent for disclosure of Part 2 information do not go far enough and may have a negative impact on patient health outcomes by undermining health plans and their provider networks’ ability to efficiently access the information they need about members with SUD, sharing that information when they receive it with the members’ care management team, and coordinating their care.

Those who suffer from SUD and go untreated are among the highest utilizers of health care services, requiring twice as much health care as those without SUD being treated for the same disorders. The barriers found in 42 CFR Part 2 and the lack of clarity as it relates to health plan operations undermine efforts to integrate behavioral and physical health services for people with SUD, ultimately leading to worse health outcomes. Therefore, ACAP’s overarching request is that the Secretary take full advantage of the flexibility in the statute to further align the requirements under 42 CFR Part 2 with the HIPAA requirements concerning the sharing of protected health information for the purposes of payment and operations and the associated notification and opt out procedures.

Concerning the specifics of the SNPRM, when a patient consents to disclosure for the purposes of payment and/or health care operations activities, Section 2.33(b) enumerates the allowable purposes for which the records can be disclosed to contractors, subcontractors and legal representatives. While ACAP supports the clarification, we strongly urge additional clarification and the inclusion of other activities.

Specifically, we advocate for the following:

  • Recognizing the critical role that state Medicaid programs play in ensuring the health status of its citizenry, the enumerated purposes should include a general provision that addresses plans meeting required provisions of a Medicaid and CHIP contract. If there are specific purposes under a Medicaid and CHIP contract that would not be allowed, they should be specified as the exception.
  • While the enumeration may provide helpful clarification, there may be activities that have not been specified but meet the intent of the regulation. Therefore, ACAP requests the addition of a more general provision that includes activities not specifically enumerated but in line with the intent of the regulations. At a minimum, there should be a provision that allows the Secretary to specify other allowable activities via subregulatory guidance. In addition, in recognition of the need to provide certainty to health plans, SAMHSA must institute a mechanism that would provide quicker clarification and responses to queries concerning whether a function falls within the allowable activities.
  • One of the most critical activities that health plan undertakes as part of its general operations is case management and care coordination. We strongly disagreed with SAMHSA’s decision that case management and care coordination should not be included as allowable QSO activities because they are “treatment” yet excluded these activities from treatment providers when discussing the use of a general consent. At a minimum, care management and care coordination should be included as a necessary health plan operational activity that ensures members are engaged in their health care, that necessary services and supports are being received, and that care is being coordinated 3 across all providers in an efficient and effective manner. Moreover, in providing case management and care coordination for other chronic conditions, it is inappropriate to not consider drug treatment as part of that care plan. In fact, failure to recognize the critical nature of this activity can result in an individual not receiving the necessary physical and behavioral health services in an integrated manner that will support them in their recovery efforts. In addition, there is the additional protection that members always have the opportunity to opt out of case management if they are not interested in participating.
  • Paragraph 2.33(b)(2) notes that clinical professional support services (e.g., quality assessment and improvement; initiatives, utilization review and management services) are an allowable service. ACAP requests that this be further clarified to include the calculation of quality measures and creation of appropriate benchmarks.
  • Paragraph 2.33(b)(3) notes that patient safety activities are an allowable activity. ACAP strongly suggest that this be further clarified to include determination of drug-drug interaction and notification of a prescriber and pharmacy provider if a medication is being prescribed that would be contraindicated for an individual receiving Medication Assisted Treatment.
  • Paragraph 2.33(b)(4) notes that activities pertaining to training, practitioner assessment and practitioner plan performance, and training of non-health care professionals are allowable and paragraph 2.33(b)(5) states that accreditation, certification, licensing, or credentialing activities are also allowable. ACAP requests that it be clarified that health plans and their contractors are allowed to make site visits and review records of a Part 2 Program Provider as part of the accreditation process and reaccreditation process.
  • Paragraph 2.33(b)(8) notes that activities related to addressing fraud, waste and abuse are allowable. ACAP assumes that when combined with Section 2.33(b)(2) it would allow the Part 2 claims information to be utilized to evaluate whether an individual is an appropriate candidate for a prescriber or pharmacy restriction program. If this is not was not a consideration in the drafting of this paragraph, ACAP requests that it should be specifically included.
  • Paragraph 2.33(b)(10) addresses business planning and development including the development or improvement of methods of payment or coverage policies. ACAP assumes that this would include activities related to the development and implementation of delivery system and payment reform. If this was not a consideration in the drafting of this paragraph, ACAP requests that it should be specifically included.
  • Federal regulations require that all Medicaid Managed Care Organizations submit encounter data to the state Medicaid agency that is used for multiple purposes. As contractors for the state, it assumed that Paragraph 2.33(b)(17) concerning the review of 4 health care services would include the submission of the required encounter data. If this was not a consideration in the drafting of this paragraph, ACAP requests that it should be specifically included.

Section 2.33(c) requires that safeguards for the disclosure of the Part 2 must be addressed in the contract. While we agree that there should be a written document, some of these safeguards would be better addressed in the Business Associates Agreement that relates back to the contract for services. Therefore, we ask that the language be modified to allow the Part 2 information safeguards to be spelled out in the contract and/or Business Associates Agreement.

We appreciate this opportunity to comment on the supplement to this important regulatory revision. If you have any questions about this response, please feel free to contact Deborah Kilstein at .


Margaret A. Murray
Chief Executive Officer

ACAP Comments 42 CFR Part 2 SNPRM