HIT Perspectives: Legislation, Proposed Rules and Part D Guidance to Affect Electronic Prescribing and EHRs

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HIT Perspectives – January 2019


Legislation, Proposed Rules and Part D Guidance to Affect Electronic Prescribing and EHRs



By Tony Schueth, Editor-in-Chief


Healthcare Compliance

Congress, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) were busy toward the end of 2018 in issuing guidance that will affect electronic prescribing (ePrescribing) and electronic health records (EHRs). The requirements were put forth as legislation, proposed rules or as a memorandum to Medicare Part D plan sponsors. We also understand that two additional regulations are waiting in the wings: one concerning electronic prior authorization (ePA) and the other concerning perceived information blocking by EHRs. In case you missed it, let’s review.

  1. Legislation mandating ePrescribing and improved interoperability for prescription drug monitoring programs (PDMPs). These are part of the bipartisan SUPPORT for Patients and Communities Act (also known as HR6). The bill mandates ePrescribing for controlled substances covered under Medicare Part D and ePA for all covered Part D drugs requiring prior authorization, effective January 1, 2021. Of note is that facsimiles, proprietary payer portals and electronic forms no longer comply with the law. The act also provides grant support to promote PDMP interoperability. (Click here for our take on the legislation and how it impacts ePrescribing and PDMPs.)
  2. Proposed rule to require use of the real-time benefit check for Part D by January 1, 2020. CMS recently issued a proposed Part D rule under which plan sponsors must adopt a “real-time benefit check (RTBC) tool” by January 1, 2020. The draft regulation also indicates that if an RTBC standard is available in a year or so, it could be adopted by Part D for 2021. Point-of-Care Partners submitted extensive comments on the proposed rule, including the timeline, adoption of standards and other implementation issues. (Click here to read our comment letter.)
  3. Part D sponsors to provide an indication-based formulary design beginning contract year (CY) 2020. According to CMS, indication-based formulary design is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications. CMS says this gives health plans the ability to negotiate formulary coverage based on specific indications. That sounds promising, but there are many details to be fleshed out by stakeholders such as CMS, EHR vendors and standards organizations. Some of these unknowns may be addressed in the final rule:
  • How will indication-based formulary information be displayed in EHRs?
  • Will vendors have enough time to meet this implementation date?
  • Are standards needed?
  • How will payers develop the information?
  • Will physicians understand it?
  • And will physicians be required to use the data?
  1. Proposed rule to rescind two HIPAA administrative simplification standards. HHS issued a proposed rule that would rescind the required use of the standard unique health plan identifier (HPID) and other entity identifier (OEID), which are part of the suite of standards named under the Health Insurance Portability and Accountability Act (HIPAA). These two standards are really oriented toward claims but payers and physicians have resisted using them. In fact, HHS has never taken enforcement actions for noncompliance with these two standards.

HHS’ action to rescind the two standards was taken in response to recommendations by the National Committee on Vital and Health Statistics in 2014 and follow-up input by stakeholders. According to HHS, the identifiers do not add value to electronic health care transactions and would be “costly, complicated and burdensome” to implement. In addition, the industry already has moved on, developing other ways to route claims and other HIPAA transactions using existing payer IDs. Comments are due February 19, so the final rule should be out in early summer. Payers and providers should be happy with HHS’ action, as they have opposed use of the standards for decades. In particular, providers were unhappy about the prospect of using HPIDs, noting that their health information technology systems were programmed to identify payers rather than plans. We wonder whether CMS’ action signals the need for HHS to update HIPAA standards and operating rules to reflect regulatory and market developments. Such a reboot would definitely have implications for ePrescribing as well as EHRs.

Speaking of HIPAA, the proposed rule does not address the elephant in the room: development of an electronic claims attachment standard under HIPAA, which has not gained any real traction since 1996. Because of the inaction, the Affordable Care Act  — passed in 2010 — included a provision requiring the federal government to issue a final rule by January 1, 2014 on standardizing electronic claims attachments. Needless to say, we’re still waiting but not holding our breath. The world has since moved on by creating standards to be used for certain types of attachments and incorporating information into EHRs. In addition, meaningful use requires 12 types of structured documents. It will be interesting to see if CMS takes up the challenge any time soon.

  1. Coming Soon. As mentioned previously, we expect there will be a proposed rule from CMS for implementing ePA provisions of the SUPPORT for Patients and Communities Act. The Office of the National Coordinator for Health Information Technology has been expected to issue a rule on interoperability and information blocking as required by the 21st Century Cures Act. We will be writing about provisions and potential impacts, so stay tuned.

Point-of-Care Partners is closely monitoring these and other legislative developments. We’d be happy to walk you through them and help you with comment submission. Drop me a line at tonys@pocp.com.