In response to https://www.federalregister.gov/documents/2023/05/26/2023-10934/medicaid-program-misclassification-of-drugs-program-administration-and-program-integrity-updates posted in the Federal Register on May 26, 2023, the Massachusetts Health Data Consortium (MHDC) and its Data Governance Collaborative (DGC) have submitted the following comment.
Founded in 1978, MHDC, a not-for-profit corporation, convenes the Massachusetts’s health information community in advancing multi-stakeholder health data collaborations. MHDC’s members include payers, providers, industry associations, state and federal agencies, technology and services companies, and consumers. The Consortium is the oldest organization of its kind in the country.
MHDC provides a variety of services to its members including educational and networking opportunities, analytics services on both the administrative and clinical side (Spotlight), and data governance and standardization efforts for both clinical and administrative data (the Data Governance Collaborative/DGC and the New England Healthcare Exchange Network, respectively).
The DGC is a collaboration between payer and provider organizations convened to discuss, design, and implement data sharing and interoperability among payers, providers, patients/members, and other interested parties who need health data. It is a one stop interoperability resource. The DGC primarily focuses on three areas:
This section comments on the general approach taken by CMS in their proposal or comments on items that cross multiple sections of the proposed rule or that do not have questions in the proposal.
There are a variety of currently proposed, pending, or expected rules from CMS and ONC that are not completely independent from each other. in some cases there may be components of different rules that contradict each other and in other cases they may be written in ways that unnecessarily increase the burden on one or more parties subject to the rule. These rules should be coordinated so that their requirements are compatible and executable without placing additional burden on individuals or organizations that need to implement more than one rule. None of these rules are implemented in a vacuum.
For example, CMS discusses requiring NDC codes for medications in this rule but the recent ONC HTI-1 proposed rule discusses the possibility of deprecating support for NDC codes in its certification programs in favor of always requiring use of RxNorm for medications. These two approaches are not compatible with each other (see comment below).
This is just one illustrative example; we ask that CMS include a review for compatibility as part of all pending, proposed, and upcoming regulations to ensure that they are consistent and compatible with each other and, when possible, include representatives from other pertinent agencies within HHS or other departments as appropriate. We understand that CMS is not responsible for the choices made by ONC (or any other entity outside of CMS), but the agencies need to work in concert to ensure that their respective rules are compatible with each other.
We ask CMS to consider the need to update industry specifications that go through substantive, formal approval processes prior to a formal adoption by a standards-setting authority when setting implementation/enforcement deadlines for provisions. For example, digital insurance card specifications (such as the CARIN Alliance Digital Insurance Card FHIR implementation guide) may need an update to add BIN and/or PCN numbers or to mandate their inclusion if already present.
USCDI is the official minimum clinical data set expected to be supported by certified health IT, various FHIR APIs, and more. As of USCDI v3 there is a section outlining minimum standards for health insurance information. We strongly suggest coordinating with ONC around the inclusion of BIN and PCN numbers in a future version of USCDI. This would ensure that, if known, these numbers are part of data exchange and remain with medication data or payer claims data across the entire healthcare ecosystem.
Participants in the DGC noted that printed Medicare Part D cards (whether standalone or included in a Medicare Advantage plan) already have BIN and PCN numbers on them and thought it important to ensure consistency between Medicare Advantage and Medicaid in the way these numbers are presented if possible. In general, similar rules across different products/types of insurance should be implemented the same way to limit duplicated efforts and accidentally applying the rules from one program to patients enrolled in another.
Note that we are not identifying any inconsistencies at this time, just suggesting that being aware of and removing them would make implementing programs across product lines significantly easier.
We understand the rationale for requiring NDC codes to support manufacturer drug rebates since NDC codes are inherently organized by manufacturer first. However, in its recent HTI-1 proposed rule, ONC made it clear that it is considering deprecating support for NDC codes and requiring the use of RxNorm for medication-related certifications in the future.
It is our understanding that RxNorm does not separately capture drug manufacturer information and thus likely will not meet the needs of a drug rebate program involving direct manufacturer attribution of medications. As noted above, CMS and ONC clearly are moving in opposing directions when it comes to which drug codes to use. If NDC codes are required for any drugs they need to be supported by certified health IT supporting medications. This is particularly true for physician-administered drugs as they are most likely given in an environment using a traditional EHR system, probably one certified using the ONC certification rules.
We further note that USCDI v1 requires the use of RxNorm for medications. However, support for NDC codes was added in USCDI v3, the version ONC will start certifying health IT against in January 2025. Prior to that date, NDC support for physician-administered drugs may not be technically possible in some environments and likely will not be supported in FHIR (and maybe other) data exchanges.
Our Data Governance Collaborative participants raised some concerns that changes made to accommodate drug rebate programs might make future attempts to standardize data exchange between payers and PBMs (and perhaps payers and pharmacies) using FHIR more difficult if not built into rule changes around medication data formats and similar. We urge you to consider this use case as a future goal when making decisions around pharmacy/medication data requirements.
This section will list specific questions asked in the proposal and provide our responses to them.
We see several benefits and several drawbacks to requiring diagnosis codes on prescriptions. Some of the benefits include:
There are quite a few potential drawbacks as well:
In addition, while not a benefit or drawback per se, medications are particularly pervasive within healthcare data systems and health data exchange. The impact of updating various specifications, health IT, APIs, workflows, e-prescribing, state controlled substance tracking systems, and other relevant data and technology systems is not minimal and may require significant leadup time prior to implementation deadlines. We do not believe this should impact any decision regarding whether to impose this change, but it should be considered in the timelines and deadlines for implementation should CMS go in this direction.
We also note that a corresponding requirement in ONC certification would likely be needed. ONC is already considering such a change; they included this topic in their HTI-1 RFI on Pharmacy Interoperability.