Trump Administration Proposes Changes to Part 2 Privacy Rules
Last Thursday, the Trump administration released a much-anticipated rule which proposes updates to the consent requirements governing the release of patient information for individuals seeking treatment for substance use disorder. The rule, developed by the Substance Abuse and Mental Health Services Administration (SAMHSA), is designed to address barriers to care coordination for providers that treat individuals with substance use disorder (SUD), while maintaining privacy safeguards for patients seeking treatment for SUD. During a call with reporters, Health and Human Services (HHS) Secretary Alex Azar acknowledged that the administration does not have the authority to fully align the 42 CFR Part 2 (or Part 2) rules with the more general consent requirements in the Health Information Portability and Accountability Act (HIPAA) – a change sought by many Members of Congress and stakeholders.
HHS noted that the basic framework for confidentiality protection of SUD patient records will not be altered under the proposed rule, and the current 42 CFR Part 2 law will continue to prohibit law enforcement use of SUD patient records in criminal prosecution and restrict the disclosure of SUD treatment records without patient consent.
However, SAMHSA’s proposal would modify several sections of the substance use privacy law to encourage care coordination among providers. The rule would update the definition of what constitutes a Part 2 record and its applicability in order to ensure providers have additional clarity about what is, or should be, protected by Part 2 and that Part 2 providers are not discouraged from caring for substance use disorder (SUD) patients or recording their information. SAMHSA also clarified that personal devices not involved in Part 2 program business do not have to be “sanitized” — i.e. record deletion — if a SUD patient accidentally messages a provider’s personal device. Additionally, non-Part 2 providers will have access to central registries to determine if a patient is enrolled in an Opioid Treatment Program (OTP) and receiving medications as part of SUD treatment to ensure at-risk patients are not accidently overprescribed or prescribed substances for which they are seeking treatment.
The administration’s announcement elicited statements of support from a variety of health care stakeholders as well as some members of Congress. House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) and Health Subcommittee Ranking Member Michael Burgess (R-TX) noted that the rule builds on the House’s efforts in passing the Overdose Prevention and Patient Safety Act. That legislation would have put the protection of SUD records under HIPAA instead of 42 CFR Part 2, although it was never taken up by the Senate.
Interested stakeholders had been eagerly awaiting the administration’s interpretation of its authority to modify the Part 2 rules to further support the coordination of care for patients receiving treatment for SUD. The rule has already led some stakeholders to renew their calls for legislative action to further align the Part 2 and HIPAA rules. HHS leaders also are continuing work on the other three regulations identified in the “Regulatory Sprint to Coordinated Care,” which is intended to promote value-based outcomes for patients by amending federal regulations that impede coordinated care among health providers.
OIG Reports National Review of Opioid Prescribing in Medicaid Not Yet Possible
The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) last week posted findings from its review of opioid prescribing in Medicaid using the Transformed Medicaid Statistical Information System (T-MSIS). Although the OIG noted that the data reviewed is critical for nationally quantifying the opioid crisis’s impact on Medicaid and for monitoring the crisis, national review is not possible at this time due to gaps and inconsistencies in data states submit through T-MSIS. The OIG stressed that the data is also important for conducting general program integrity efforts across states.
OIG wrote that until T-MSIS data are complete in all states and limitations across states are addressed, it will not be possible to conduct a national evaluation of Medicaid beneficiaries at risk of opioid misuse or overdose. According to CMS, Medicaid covered over 31 million prescriptions for opioids in 2017. The data OIG reviewed are critical for nationally quantifying the opioid crisis’s impact on Medicaid and for monitoring the crisis, as well as for conducting general program integrity efforts across States. OIG also stated that without a unique beneficiary ID, it is not possible to identify all at-risk beneficiaries in need of opioid-related treatment and to take appropriate action, or to monitor utilization of services to protect beneficiaries from poorly coordinated care. Additionally, it is not possible without a diagnosis code to exclude all patients with cancer diagnoses for whom higher doses of opioids may be appropriate, or to identify patients’ medical conditions to determine medical necessity for services.
OIG recommended that CMS take several actions to ensure the identification of at-risk beneficiaries and providers who may be overprescribing including: (1) work with states to address instances in which a single beneficiary has more than one Medicaid ID within a state; (2) work to ensure that —in cases in which a beneficiary was enrolled in more than one state over time — claims for individual beneficiaries can be linked across states; (3) prioritize correct and complete state reporting of prescriber NPIs; and (4) issue guidance to clarify which services require a diagnosis code. CMS notified the OIG they agreed with their recommendations and inform them of plans to correct these issue areas.
SAMHSA Releases Annual Drug and Mental Health Report
Last Tuesday, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its annual report of the National Survey on Drug Use and Health (NSDUH). In a statement accompanying the release, Health and Human Services Secretary Alex Azar touted the progress that has been made in addressing the misuse of pain relievers and abuse of heroin while also acknowledging that millions of Americans are still not receiving the treatment they need.
The report highlights the survey’s findings on co-occurring SUD and serious mental illnesses (SMI). In 2018, 27.6 million U.S. adults had a SUD and/or SMI, 3.2 million of whom had both. Of U.S. adults with an SMI, 14.6 percent were found to use opioids over the past year. Meanwhile, 3.7 percent of all U.S adults had a co-occurring SUD and any mental illness, up 0.3 percentage points from 2017. The survey also found that 9.9 million people in the U.S. ages 12 and older misused pain relief medication in the past year.
According to HHS’ Assistant Secretary for Mental Health and Substance Use, Dr. Elinore McCance-Katz, the data indicate a need to focus resources on several issues, including the ongoing opioid epidemic, the rising rates of major depression in adolescents and adults 18-49 years old, and ongoing efforts in SUD prevention. In a presentation of the data, Dr. McCance-Katz indicated that SAMHSA will prioritize national training and technical assistance programs that help clinicians to be prepared to assess and treat mental health issues and substance issues. She also reiterated SAMHSA’s support for several grant programs aimed at helping states to address their opioids crisis needs in terms of prevention, treatment, and community recovery resources.
Trump Administration Appeals Ruling Blocking Drug Prices in DTC Ads
The Department of Health and Human Services (HHS) last Wednesday appealed the July court ruling blocking the Trump Administration regulation that would have required drug manufacturers to disclose list prices in direct-to-consumer (DTC) television ads. Under the rule, which was announced by HHS Secretary Alex Azar in May, drug manufacturers would have to state the list price of a 30-day supply of any drug that is covered through Medicare and Medicaid and costs at least $35 a month. The regulation was struck down July 8 by federal judge Amit Mehta — hours before it was slated to go into effect — after he found Congress had not given HHS sufficient authority to require such price disclosures. HHS has not revealed what argument it will pursue, but Merck, Amgen and Eli Lilly, and the Association of National Advertisers (ANA) have stated they are confident they are in strong legal standing on both points they argued. They originally argued on the lack of authority the HHS has to adopt the ruling and that the regulation violates the First Amendment —which was not addressed in the July 8 ruling.