Washington Debrief: MACRA Reg is Out!

Federal Affairs:

Key Takeaway: The MACRA proposed regulation has hit the street.  CMS published it April 27^th.   

Why it Matters: In an unusual move, CMS published the long-anticipated proposed rule on the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) program stemming from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) of 2015. Collectively, CMS is referring to these programs as the Quality Payment Program. CMS says their goal with the Quality Payment Program is to continue to support health care quality, efficiency, and patient safety.

MACRA reforms the long-time sustainable growth rate formula dictating the way physicians and other clinicians are paid and replaces it with a new system that rewards value and outcomes.  The law also consolidates the current Meaningful Use, Physician Quality Reporting System, and Value-based Payment Modifier programs.  Components of each are a part of the new system. 

CMS states they are, “focused on three core strategies to drive continued progress and improvement.” These include: 1) Focusing on improving the way clinicians are paid to incentivize quality and value of care over simply quantity of services; 2) improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making; and 3) making data more available and enabling the use of certified EHR technology to support care delivery.  Below is a high-level overview of some of the key pieces:

• Reporting: Full, calendar year reporting (2017 performance year for 2019 payment)
• Applies to: Medicare Part B clinicians, including physicians, physician assistants, nurse practitioners, clinical nurse specialist, and certified registered nurse anesthetists.
• The Score: Clinicians will be assessed on a 100 point scale known as the Composite Performance Score or CPS:
  • Quality: 50% of total score
  • Resource Use: 10% of total score
  • Clinical Practice Improvement Activities (CPIA): 15% of total score
  • Advancing Care Information (formerly Meaningful Use): 25% of total score
• The Program Formerly Known as MU: Is now “Advancing Care Information” (see pages 198-235 of the rule)
  • 25 percent of total CPI score
  • ACI made up of a total of 100 points involving two main areas: 1) base score (50%); 2) performance score (80%); and 3) chance for a bonus point for public health and clinical data registry reporting
  • Way to exceed 100 points but if you do you just get full 25% ACI category
  • Base Score involves reporting the numerator (of at least one) and denominator for 6 objectives comprising 11 measures total plus an option to meet 4 additional public health reporting measures [SEE TABLE 6 of the rule]
  • Failing to attest to meet any submission criteria and measure specifications for any measure results in a score of zero for the entire ACI category.
  • To receive the base score, clinicians must provide the numerator/denominator or yes/no for each objective and measure. Only “yes” responses count.
  • CMS has proposed removing the thresholds that apply under Stage 3. The performance score would be calculated based performance on eight measures for a total of 80 points with up to ten percent per measure.  Clinicians select the measures that best fit their practice. Example – Clinicians sends 31% of their patients (or responds) a secure message, the score under secure messaging would be 3.1%.  [SEE TABLE 9 for a sample performance score]

• Privacy mandatory: Clinicians must achieve the Protect Patient Health Information objective to receive any score in the Advance Care Information performance category.
• CPOE and CDS: Clinical Decision Support and the Computerized Provider Order Entry are no longer required.  However, under an alternate proposal CMS offered they could be included.

• Data Blocking: This applies to both clinicians and hospitals.  Providers would as part of their attestation process attest they did not engage in data blocking.  Specifically they would need to attest they:
  • Did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology.
  • They implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: connected in accordance with applicable law; compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; implemented in a manner that allowed for timely access by patients to their electronic health information; (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 USC 300jj(3)), including unaffiliated providers, and with disparate certified EHR technology and vendors.
  • Responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 USC 300jj(3)), and other persons, regardless of the requestor’s affiliation or technology vendor.
• Other Attestation requirements: Clinicians and hospitals will be required to demonstrate its cooperation with authorized surveillance and oversight activities.
• Key Resources:
  • Proposed Rule
  • CMS Fact Sheet
  • CMS QPP webpage

CHIME Submits Comments of Medical Device Interoperability

Key Takeway: CHIME responds to FDA draft pre-market guidance on device interoperability.

Why it Matters: CHIME submitted responses to the FDA welcoming the added attention to device interoperability.  Members continue to express challenges getting devices to connect to EHRs and other systems.  A key theme throughout the letter was the need for more transparency around device capabilities. Specifically, we recommended the FDA:

1. Collaborate with the Office of the National Coordinator (ONC), providers, device manufacturers, other appropriate stakeholders to establish a baseline set of uniform interoperability standards for devices that must be met in order to receive FDA approval.
2. Work with ONC and interested stakeholders to establish a more robust definition of interoperability.
3. Work with ONC to have them certify APIs.
4. Synchronize efforts across with other federal agencies in applying risk management principles.
5. Require that device manufacturers to perform a risk assessment annually on their devices.
6. Ensure alignment between the FDA’s cybersecurity guidance for device manufacturers and the interoperability guidance.
7. Require device functionality receive the same level of transparency as EHRs.
8. Create a central, online database that includes key functionality of devices (i.e. interoperability and security).

Congressional Affairs:

Congressional Interest in Meaningful Use Program Changes Continues, REBOOT Group Reemerges

Key Takeaway: Despite the release of the Medicare Access and CHIP Reauthorization Act rules that included changes to the Meaningful Use Program for Medicare physicians, key Congressional leaders continue to urge the Administration to make improvements to the Program for hospitals and physicians alike.

Why It Matters: Last week the Senate REBOOT Group, a collection of six Republican Senators, sent a letter and draft legislation to the Secretary of the Department of Health and Human Services, Sylvia Burwell, urging flexibility be offered to all participants in the Meaningful Use Program, requesting technical assistance with the accompanying draft legislation.

The six Senators, John Thune (R-SD), Lamar Alexander (R-TN), Mike Enzi (R-WY), Pat Roberts (R-KS), Richard Burr (R-NC) and Bill Cassidy (R-LA), included a proposal for a 90-day reporting period under Meaningful Use, as well as a relaxation of the all-or-nothing program construct that would revise the definition of a “Meaningful User” to a participant that has met 75 percent of the Program’s measures.

The REBOOT group first emerged with a report in 2013, “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT.” The group penned a blog on Health Affairs as a follow-up last year.

A key component of the REBOOT proposal was the request for the Program changes to be made for both eligible hospitals and eligible physicians alike, a sentiment that was shared by the leadership of the Senate Committee on Finance in a letter sent to Acting Administrator Andy Slavitt concerning the then- forthcoming MACRA regulations.

In the letter from Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR), the members urged the Centers of Medicare and Medicaid Services to extend the flexibility afford to physicians in the Meaningful Use Program to hospitals too. They wrote, “White the MACRA statute does not pertain to hospitals, CMS should strive to provide as much of the same flexibility to eligible hospitals as possible, consistent with the MU program statutory language.” The further encouraged the Administration to work with the Committee concerning statutory limitations that would prevent CMS from making the discussed improvements.