On June 24, 2024, the Division of Well being and Human Companies (“HHS”) launched a last rule (“Disincentives Ultimate Rule”) establishing disincentives for sure healthcare suppliers which have dedicated data blocking. The data blocking disincentives instantly affect Medicare-enrolled healthcare suppliers or suppliers together with hospitals, important entry hospitals, MIPS-eligible clinicians, and ACOs. The Disincentives Ultimate Rule has been submitted to the Workplace of the Federal Register for publication and can turn into efficient 30 days after Federal Register publication.
Data blocking happens when a well being care supplier knowingly engages in a apply that unreasonably and certain interferes with, prevents, or materially discourages the entry, change, or use of digital well being data, until in any other case required by legislation or lined by an exception. Examples of data blockings embrace:
- Contract limitations that prohibit a doctor’s use and change of medical data;
- Charging extreme charges to create digital well being file (“EHR”) interfaces or connections with different data expertise entities;
- Utilizing technical or non-standardized strategies of implementing EHR and different well being data expertise that block the entry, change, or use of medical data.
The Disincentives Ultimate Rule was created pursuant to the twenty first Century Cures Act, and established “disincentives” or destructive situations for well being care suppliers which are discovered to be in violation as decided by an OIG investigation.
Well being care suppliers topic to the Disincentives Ultimate Rule should be Medicare-enrolled suppliers or suppliers. This rule goes hand-in-hand with the OIG’s June 2023 last rule that established civil financial penalties of as much as $1 million per violation in opposition to data blocking actors, however excluded healthcare suppliers. For extra Crowell insights on that rule, see our prior shopper alert.
Upon an OIG discovering {that a} well being care supplier has dedicated data blocking and referred the celebration to CMS, the well being care supplier is topic to 3 main disincentives:
- Sure hospitals shall be ineligible for significant EHR consumer standing. The Medicare Selling Interoperability (PI) Program establishes that eligible hospitals and important entry hospitals that interact in data blocking shall be ineligible for annual market-based financial will increase granted to qualifying EHR customers. Hospitals topic to this disincentive could be ineligible to earn the three quarters of the annual market basket improve related to qualifying significant EHR customers. Important entry hospitals could have its fee diminished from 101% to 100% of cheap prices it might need in any other case earned in an relevant 12 months.
- Advantage-based Incentive Fee System (MIPS) eligible clinicians is not going to be significant EHR customers. MIPS clinicians who’ve dedicated data blocking is not going to be thought of significant EHR customers and can obtain a zero rating within the MIPS Selling Interoperability efficiency class. The rating is usually 1 / 4 of a person MIPS eligible clinician’s complete last rating in a efficiency interval/MIPS fee 12 months, until an exception applies and the MIPS eligible clinician isn’t required to report measures for the efficiency class. This disincentive applies solely to the person even when she or he studies as a part of a gaggle.
- Accountable care group (“ACO”) individuals, suppliers, or suppliers could also be ineligible to take part within the Medicare Shared Financial savings Program (MSSP) for not less than one 12 months. ACO suppliers discovered to have dedicated data blocking might not obtain income they might in any other case have earned via the Shared Financial savings Program. Earlier than making use of this disincentive, CMS will think about “related details and circumstances” which embrace, however aren’t restricted to the next:
- the character of the well being care supplier’s data blocking;
- the well being care supplier’s diligence in figuring out and correcting the issue;
- the time because the data blocking occurred; and
- whether or not the supplier was discovered to be an data blocker beforehand.
Lastly, HHS might set up extra disincentives via future rulemaking.
Key Takeaways
As we beforehand famous, the disincentives apply to well being care suppliers which are eligible for enumerated applications however not, for instance, pharmacists, pharmacies or laboratories which are actors below the ONC Data Blocking Rule however don’t take part within the PI, MIPS or MSSP. Any appeals of the disincentives are solely out there below present authorities of the suitable companies and aren’t particularly offered below the Cures Act for the OIG’s findings of data blocking. It’s important for impacted well being care suppliers to evaluate their insurance policies and practices in opposition to the data blocking necessities and develop (or confirm the institution of) organizational insurance policies and practices to guarantee compliance with the data blocking guidelines and keep away from violations.
For extra data on how this Rule may affect your group or for additional steering on how your group can put together for compliance, please contact our workforce.
