HHS Postpones Publication of Anticipated 340B Rules – HHS recently announced delays to several rules and policies related to the 340B Drug Pricing Program. Policies postponed for later publication include the final 340B Omnibus Guidance, the Civil Monetary Penalties and Ceiling Price final rule, and the Administrative Dispute Resolution Process proposed rule.
Stakeholders have anticipated the release of the 340B Omnibus Guidance (also referred to as the “mega-guidance”) following litigation that invalidated previous rules related to the Program. The omnibus guidance is expected to address and update a number of key policies, including defining eligible patients and provider sites that may receive these drugs, as well as the types of drugs that are available for discount. The Health Resources and Services Administration (HRSA), which administers the 340B Program, now says the omnibus guidance will be available in December.
The other delayed rules, required by the Affordable Care Act, would allow OIG to demand civil monetary penalties from drug manufacturers that had intentionally overcharged hospitals and other covered entities for drugs used in the 340B Program, and establish an administrative dispute resolution process for covered entities involved in the Program. Those rules are now slated to publish in November and September, respectively.
The Spring 2016 Regulatory Agenda, which provides a preview of regulations expected to publish during the final months of President Obama’s administration, published on May 18, 2016. You can read the Spring 2016 Regulatory Agenda here.
HHS Explains There Are No Set Caps on Fees for Access to Medical Records – In a newly released FAQ, HHS clarified that there is no set limit under HIPAA for the fees that can be charged to patients for access to their medical records. A covered entity may calculate allowable fees by (1) calculating actual allowable costs, or (2) by using a schedule of costs based on average allowable labor costs. Alternatively, for electronic copies of records maintained electronically, covered entities may charge a flat fee not to exceed $6.50. HHS explained that this flat rate option is available for entities that do not want to go through the process of calculating actual or allowable costs. However, an entity may still charge a fee based on actual allowable costs—perhaps in response to an unusual request—provided that the entity informs the individual in advance of the approximate fee. Please click here to read the full FAQ.
CMS Announces New Initiatives to Reduce Hospital Readmissions – Last week, CMS announced the development of Hospital Improvement and Innovation Networks (HIINs), organizations intended to work collaboratively with quality improvement organizations (QIOs), hospital associations, and health systems to implement evidence-based best practices for quality improvement. These HIINs are expected to build on the work of Hospital Engagement Networks (HENs) established under CMS’ Partnership for Patients initiative. Through HIINS, CMS hopes to see a 20 percent reduction in overall patient harm and 12 percent reduction in 30-day hospital readmissions by 2019. Find out more about the HIINS initiative here. Organizations interested in supporting this effort can submit a proposal no later than June 27.
