Final Rule Summary – Key Issues Related to Clinical Decision Support

The ACR and RBMA have done a good job of summarizing the MPFS Final rule in terms of commenting on and discussing its implications on the use of CDS in the Quality Programs, CMS’s site neutral payment policy, reimbursement cuts, etc.

My summary below focuses on the nuances of a few specific areas related to CDS.  I typically copied portions of comments CMS received and their response to them. I also include a few brief personal comments for each area.

This summary covers the following topics:

·        Delayed Implementation

·        Critical Access Hospitals

·        Delegation of Consult Requirements to Others

·        Handling of Replacement Orders

·        G codes replaced by Unique Identifier for Claims Filing Purposes

·        Emergency Services

·        Priority Clinical Areas

I copied the relevant portion from the Final Rule for each section below, along with the page number for those interested in reading it in greater detail.  Click here to download the MPFS Final Rule in pdf format.

CDS Delay until January 2020 – Page 590

[CMS] In response to public comments we are further delaying the effective date for the AUC consultation and reporting requirements for this program from January 1, 2019 as proposed to January 1, 2020. We are also finalizing a voluntary period during which early adopters can begin reporting limited consultation information on Medicare claims from July 2018 through December 2019. During the voluntary period there is no requirement for ordering professionals to consult AUC or furnishing professionals to report information related to the consultation. On January 1, 2020, the program will begin with an educational and operations testing period and during this time we will continue to pay claims whether or not they correctly include such information. Ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2020, and furnishing professionals must report the AUC consultation information on the Medicare claim for these services ordered on or after January 1, 2020.

Bohl comment: The start date is delayed from January 1, 2019 to January 1, 2020. Ordering professionals must consult a CDS mechanism beginning January 1, 2020 and Furnishing professionals are to put the consultation information on their claims, but CMS will pay claims without regard to the information’s presence on the claim through 2020. Beginning January 2021 claims will only be paid if they fully meet the claims submission requirements.

 Critical Access Hospitals – page 597

Public Comment: A few commenters asked if orders for advanced diagnostic imaging services for patients in critical access hospitals (CAHs) are subject to the AUC consultation and reporting requirement.

CMS Response: Any advanced imaging service furnished within a CAH would not be furnished in an applicable setting.

Bohl comment: Services performed at Critical Access Hospitals are not subject to this requirement. This means ordering physicians can order exams without performing a consultation and neither Critical Access Hospitals nor the interpreting physicians need to put the consultation information on their claims for payment purposes.

 Can Physicians Delegate the Consultation to Others or Even to a Third-party Agent? – Page 588

Public Comment: Numerous commenters requested clarification regarding who is required to perform the consultation of AUC through a qualified CDSM. Commenters questioned whether a designee within an ordering professional’s practice could consult on behalf of the ordering professional and whether an ordering professional could delegate consultation authority to another individual, a third party vendor or contracted agent. Some commenters supported delegation only to the ordering professional’s staff while other commenters opposed allowing consultation by anyone other than the ordering professional, which they understand as the clear requirement under section 1834(q) of the Act and the current AUC regulations, and are concerned that other types of individuals and stakeholders are preparing to circumvent this requirement by performing consultations on behalf of ordering professionals.

CMS Response: Section 1834(q)(4)(A)(i) of the Act requires an ordering professional to consult with a qualified CDSM. We appreciate the varying opinions presented by stakeholders and the number of commenters who raised these questions. We will consider developing policy to address this issue.

Bohl comment: As it stands right now, CMS is restating the language contained in the law which states the ordering professional must perform the consultation. However, you should expect further clarification in either 2018n or 2019 as to whether CMS will allow someone else to perform the consultation on their behalf, e.g., their nurse, medical assistant, or perhaps even someone outside their practice.

 Handling of Replacement Orders – Pages 589-590

Public Comment: Some commenters requested that we clarify how imaging replacement orders, where the furnishing professional or radiology technician updates or modifies an order based on new information at the time of imaging, are handled under the AUC program. One commenter requested that CMS provide guidance for situations where the furnishing professional performs different or additional tests than ordered in accordance with guidance in Medicare publication 100- 02, Chapter 15, sections 80.6.2-4.

Some commenters recommended that furnishing professionals have the flexibility to adjust exam parameters or modify orders without consulting AUC, submit orders themselves if they have relevant patient clinical information, and occasionally use AUC as appropriate to demonstrate that a test was warranted.

CMS Response: We understand that in certain situations updates or modifications to orders for advanced diagnostic imaging services may be warranted once the beneficiary is under the care of the furnishing professional. As a commenter noted, the Medicare Benefit Policy Manual (Pub. 100-02) addresses rules around these situations in Chapter 15, sections 80.6.2-4. We do not believe it was the intent of section 218(b) of the PAMA to reverse these rules, and we expect furnishing professionals and facilities to continue to adhere to them so as to avoid additional burden, workflow interruptions and delays in medically necessary services. In instances when the furnishing professional must update or modify the order for an advanced diagnostic imaging service, the AUC consultation information provided by CMS-1676-F 590 the ordering professional with the original order should be reflected on the Medicare claim to demonstrate that the requisite AUC consultation occurred. In future rulemaking, we expect to establish a means to account for instances when the order must be updated or modified. We anticipate addressing this issue in rulemaking to develop policies relating to the identification of outlier ordering professionals, and in order to inform the prior authorization component of this program.

Bohl comment: This is interesting. If the facility changes the order, CMS (for the time being) is telling us we should still report the original consultation result on our claim to show proof of the consultation for payment purposes. Good to know. Expect further clarification in future rules.

 G Codes & Modifiers Replaced by Unique Identifier – Pages 594-596

[CMS] Many commenters suggested CMS require the unique consultation identifier be appended to the Medicare claim instead of using G-code and modifier combinations. Other commenters suggested a registry to hold all AUC consultation information across CDSMs and that the information be available to CMS directly from the registry rather than having furnishing professionals report information on the claim.  In response to these comments we will not move forward with the G-code and modifier combinations for reporting which CDSM is consulted, adherence, non-adherence or situations where AUC are not applicable. We will further explore and pursue use of the unique consultation identifier for reporting on Medicare claims. However, in order to use such an identifier we must work with stakeholders to develop a standard taxonomy. We expect to conduct stakeholder outreach during 2018 so that such standardization can be accomplished and CMS-1676-F 596 will discuss such changes in future rulemaking ahead of the 2020 consulting and reporting effective date.

Bohl comment: This is great news. Use of a single unique consultation identifier (think preauth number) is far superior, and easier, than trying to manage a long set of G codes (one for each mechanism) and then applying one of three adherence modifiers.

 Emergency Services – Page 582

[CMS] Section 1834(q)(4)(C) of the Act provides for certain exceptions to the AUC consultation and reporting requirements including in the case of certain emergency services, inpatient services paid under Medicare Part A, and ordering professionals who obtain an exception due to a significant hardship. In the CY 2017 PFS final rule, we identified the circumstances specific to ordering professionals under which consulting and reporting requirements are not required. These include orders for applicable imaging services: (1) for emergency services when provided to individuals with emergency medical conditions as defined in section 1867(e)(1) of the Act; (2) for an inpatient and for which payment is made under Medicare Part A; and (3) by ordering professionals who are granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year under 42 CFR 495.102(d)(4), except for those granted such an exception under §495.102(d)(4)(iv)(C).

Bohl comment: Not much new here. Exams ordered on ER patients with emergency medical conditions as defined in section 1867(e)(1) of the Act do not need a consultation. Here is the definition taken verbatim from section 1867(e)(1) of the Act

1)     The term “emergency medical condition” means—

a)      a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in—

i)       placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,

ii)      serious impairment to bodily functions, or

iii)    serious dysfunction of any bodily organ or part; or

b)     with respect to a pregnant woman who is having contractions—

i)       that there is inadequate time to effect a safe transfer to another hospital before delivery, or

ii)      that transfer may pose a threat to the health or safety of the woman or the unborn child.

Still a lot of room for ambiguity.

 Priority Clinical Areas – Pages 591-592

[CMS] We believe that, unless a statutory exception applies, an AUC consultation must take place for every order for an applicable imaging service furnished in an applicable setting and paid under an applicable payment system. We further believe that section 1834(q)(4)(B) of the Act accounts for the possibility that AUC may not be available in a particular qualified CDSM to address every applicable imaging service that might be ordered; and thus, the furnishing professional can meet the requirement to report information on the ordering professional’s AUC consultation by indicating that AUC is not applicable to the service ordered. We remind readers that, as required under §414.94(g)(1)(iii), qualified CDSMs must make available, at a minimum, AUC that reasonably address common and important clinical scenarios within all priority clinical areas. As discussed in the CY 2017 PFS final rule (81 FR 80170), the current list of priority clinical areas represents about 40 percent of advanced diagnostic imaging services paid for by Medicare in 2014. We also remind readers that consistent with section 1834(q)(4)(A) of the Act, ordering professionals must consult AUC for every advanced diagnostic imaging service ordered. Although section 1834(q)(4)(B) of the statute does not prohibit qualified CDSMs to return a response of “not applicable” if a CMS-1676-F 592 qualified CDSM does not contain specified applicable AUC for the service ordered, we expect these situations to be limited in scope and number, and to decrease over time. The “not applicable” responses should decrease as qualified PLEs continue to build out their AUC libraries and qualified CDSMs update their content and potentially collaborate with more qualified PLEs so as to make available highly comprehensive tools.

Bohl comment: This section acknowledges that some CDS mechanisms, while they must evaluate all priority clinical areas, may not address all clinical areas for all advanced diagnostic imaging services. By making this statement, CMS is confirming that, even when using a limited system that is known to not evaluate that clinical use area, and therefore will return a “not applicable” result, the ordering physician is still required to perform the consultation and get the not applicable result. In short, providers cannot get around the consultation requirement by using mechanisms with limited use criteria sets.

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