On December 14, 2018, the Department of Health and Human Services (“HHS”) issued a request for information (“RFI”), asking for feedback on how to change certain regulations issued pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”). The RFI seeks information on how best to remove obstacles to efficient care coordination while also protecting patients’ health information, as well as how to encourage providers to share information for treatment and care coordination, making it easier to share information with parents and caregivers in dealing with the opioid crisis. Comments or information regarding changes to the HIPAA regulations must be submitted to HHS on or before February 12, 2019. Then, the agency will still need to go through the regulatory rulemaking process to implement any proposed changes after the RFI process is complete.
Specifically, the RFI requests comments and information on a number of potential changes to the HIPAA Privacy Rule, including changes that:
- encourage, incentivize, or require covered entities to disclose PHI to other covered entities;
- encourage covered entities, particularly providers, to share treatment information with parents, loved ones, and caregivers of adults facing health emergencies, with a particular focus on the opioid crisis and individuals with serious mental illness;
- seek to minimize regulatory burdens and disincentives to the adoption and use of interoperable EHRs, while still providing helpful information to individuals regarding disclosures of PHI; and
- eliminate or modify the requirement for covered entities to make a good faith effort to obtain individuals’ written acknowledgment of receipt of providers’ Notice of Privacy Practices.
While the RFI touches upon some care coordination issues present in the opioid epidemic context (such as coordination between multi-disciplinary teams and between substance abuse providers), the contemplated changes are only to HIPAA, and not 42 CFR part 2, the regulations that govern the confidentiality of alcohol and drug abuse patient records. However, HHS recently announced that it also intends to release a notice of proposed rulemaking on broad changes to 42 CFR part 2 to remove barriers to coordinated care and permit additional sharing of information among providers. That notice of proposed rulemaking is expected in March 2019. This move was likely triggered by a failed bill in Congress that would have aligned 42 CFR part 2 with HIPAA.
Regulatory Sprint to Coordinated Care
Notably, the HIPAA RFI discussed above follows on two other requests for information (or RFIs) issued this summer by CMS and the Office of Inspector General (“OIG”), as part of the Regulatory Sprint to Coordinated Care. In those RFIs, the applicable regulatory agencies acknowledged that current fraud and abuse laws may be potential barriers to value-based care and sought input regarding potential revisions to the federal physician self-referral statute (otherwise known as the Stark law), federal anti-kickback statute, and civil monetary penalties statute to better facilitate value based care. Those RFIs along with this RFI, indicate a recognition by the federal government that some potentially unnecessary hurdles currently exist which may be hampering providers’ ability to implement value-based care models or otherwise work together efficiently for care coordination of patients.
To learn more about this issue, please contact Amy Joseph at 617-532.2702 in the Boston office or Alicia Macklin at 310.551.8161 in the Los Angeles office or your regular Hooper, Lundy & Bookman contact.
 Medicare Program; Request for Information Regarding Physician Self-Referral Law, 83 Fed. Reg. 29524 (June 25, 2018); Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP, 83 Fed. Reg. 43607 (Aug. 27, 2018).