MACRA Final Rule is Here!

Meaningful Use

MACRA Final rule is here!!

Key Takeaway: CMS has released the much anticipated final rule on MACRA.

Why it Matters: On Friday morning, CMS released the final rule on MACRA.  As a recap, this rule replaces the Meaningful Use, Physician Quality Reporting System (PQRS) and the Value-based Modifier (VBM) programs which sunset for physicians and other clinicians the end of 2016 and will be replaced with a new, all-encompassing program known as the Quality Payment Program or the QPP.  Under the QPP there are two pathways for clinicians: 1) the Merit-based Incentive program (MIPS); and 2) Advanced Alternative Payment Models (APMs).

So, what’s new?  The rule is 2,398 pages.  Upon initial review, cursory review and based upon calls with CMS, a number of changes favorable to clinicians were made.  CMS has increased the number of reporting period options to reduce the likelihood of a clinician experiencing a financial penalty. Under MIPS they have also reduced the number of reporting requirements. For instance, under the “Advancing Care Information” category which takes the place of Meaningful Use, they reduced the number of measures a clinician would need to meet from 11 to 5.  And, they announced more pathways for clinicians to participate in advanced, APMs.  For example, they plan on creating a new Advanced APM I 2018 (ACO track 1) that will offer a lower level of risk than other ACOs and will be re-opening rules that were already finalized on other ACO models (like CPC+) to explore ways to make them advanced APMs. Taken together, these changes provide more flexibility for providers. 

Finally, CMS appears to have retained much of their proposal around attestations for data blocking which call on both clinicians and hospitals to attest that they did not engage in data blocking. However, they clarified that providers, “should not be held responsible for adherence to health IT certification standards or other technical details of health IT implementation that are beyond their expertise or control.”

As we dive deeper in the rule we will share more information. As always, the devil is in the details. Since the rule is “final with comment” CHIME will be creating a working group to respond.  Email us if you want to partake in the MACRA fun. Workgroup dates: October 21 & 28 and November 11 and 17.  Details to follow.

Links to CMS Fact rule, fact sheet, blog and summaries:

• Final rule with comment
• New CMS QPP overview website
  • Advancing Care Information tab
• QPP Fact Sheet
• Executive summary of the rule
• Administrator Slavitt’s blog

ONC Releases CEHRT Oversight Rule

Key Takeaway: ONC releases their final rule outlining plans for added oversight of certified EHRs (CEHRT)

Why it Matters: ONC released their rule last Friday as well, timing the release to coincide with that of the CMS MACRA rule.  Readers may recall that in March ONC proposed a rule calling for additional oversight of CERHRT.  In the rule they called for expanding their current enforcement to include direct ONC review authority.  Presently surveillance is just handled by surveillance of CERHT by ONC-Authorized Certification Bodies (ATBs). ONC’s justification for this was the need to ensure certified products are performing as intended and for safety reasons. 

The Health Information Technology for Economic and Clinical Health (HITECH) requires ONC to establish a voluntary certification program for health IT. Accordingly, healthcare providers are required to use a certified EHR as part of their participation in Medicare. ONC notes that it delegated authority to certify products to the ONC- ACBs, whose scope is generally limited to “conformance determinations for health IT evaluated against adopted certification criteria with minimal determinations for health IT against other regulatory requirements.” In some cases, ONC notes, “these non-conformities may pose a risk to public health or safety, including, for example, capabilities (certified or uncertified) of health IT directly contributing to or causing medical errors.” Presently, however, there’s no mechanism to address such non-conformities.

ONC proposed expanding their authority to surveillance of eleven areas contained in HITECH, the law that brought us Meaningful Use.  In the final rule, ONC clarifies they plan on limiting their scope of direct review to just those areas where they deem patient safety to be a concern. As we dive into this 257-paghe rule we will bring you more details.

ONC rule, summary, fact sheet, blog and press release:                

• Final rule
• Fact sheet
• ONC blog
• Press statement

Quality Measurement

Government Watchdog Highlights Need for Quality Measure Alignment

Key Takeaway: The Government Accountability Office (GAO) highlighted the need for the Department of Health and Human Services (HHS) to improve prioritization and coordination of clinical quality measures.

Why It Matters: CHIME has consistently advocated for reasonably policies to government the development, capture and reporting of clinical quality measures. The GAO report released publically last week highlights many of the challenges voiced by the industry relative to quality measure reporting.

The report was called for the Medicare Access and CHIP Reauthorization Act (MACRA), which replaced Medicare’s Sustainable Growth Rate (SGR.) GAO found that CMS has not adequately prioritized how to target the development of new measures that carry greater value in order to address ongoing misalignment concerns. Further, GAO found that CMS has not set timelines and methods to track its progress on quality measure improvement.

GAO made two broad recommendations, with which HHS concurred:

1. Prioritize its development of electronic quality measures and related data elements for the core measures it and private payers have agreed to use.
2. Comprehensively plan, including setting timelines for, its efforts to develop more meaningful quality measures.

Patient Safety

FDA Releases Guidance on Software as a Medical Device

Key Takeaway: Last week the Food and Drug Administration (FDA) released guidance on when software constitutes a medical device.

Why It Matters: The draft guidance, developed with the International Medical Device Regulators Forum, outlines medical software, the subset of health software that is actually regulated by the FDA.

The International Medical Device Regulators Forum, a joint effort with regulators from the U.S., China, Canada, Australia, Brazil, the EU, Japan and Russia, is aimed to improve coordination of how devices are evaluated and regulated. 

The draft guidance outlines software based on risk profile and suggests that regulatory efforts be directed at the higher risk software. Further, the FDA outlines their interpretation what constitutes risk relative to medical software. The guidance is open for comment for 60 days.