If you are like most people I encounter these days, you don’t have a free moment to catch up on items which do not have a deadline of “TODAY”. Understandable, because there is a lot going on this quarter from financial audits to program audits to timeliness monitoring to everything else on your plate.
On March 15, the Centers for Medicare & Medicaid Services (CMS) released their revised Civil Money Penalty calculation methodology for comment (bottom of this page). The proposed changes include:
- Clarifying how per determination standard penalties are calculated for Program of All-Inclusive Care for the Elderly organizations (which is “consistent with our statutory and regulatory authority”)
- Proposing to add an aggravating factor for enrollees who never received their Part C services or Part D medications due to violation of program requirements
- The section used to refer to delay/denial of drugs, but now includes reference to enrollee never receiving their Part C service or Part D medication. It makes sense as it steps up the severity of access to Part C services.
- Changes to existing aggravating factors
- Proposing to remove aggravating factors previously identified as common conditions in audit and enforcement reports
- Proposing to remove the reference to Evidence of Coverage from an aggravating factor
- Proposing to change reference from 24 hours to one day relative to the aggravating factor for delay/denial of prescription drugs for acute conditions
- Proposing a method for increasing penalty amounts, whereby the agency tracks the accrual of penalty amounts each year, but updates the standard penalty amount no more often than every three years.
Additional nuanced changes not included in the introductory memo include:
- A note confirming the agency is also applying this new methodology to Medicare Medicaid Plans, Cost Plans, and PACE organizations and inclusion of regulatory authority references
- A note reserving the right to use different methodology as permitted by law depending on various circumstances
- A change in reference to regulation for “a complete list of the reasons that may lead to a determination” to “examples of bases that may lead to a determination”
- Clarification that CMS may calculate a per determination penalty if the per enrollee impact cannot be analyzed (meaning, you provided the Impact Analysis but CMS cannot analyze it)
- Reference to access to enrollee rights under Beneficiary Impact, namely the appeals process, has been included in examples of a sponsor’s deficiency which could adversely affect the enrollee physically
- This could be seen as a significant change, or as further clarification of what is meant by Beneficiary Impact. The section includes the more direct examples of not receiving a medication or service. However, if a beneficiary is not aware a service has been denied, in general, the provider simply does not provide or order the service. In the case of a claim denial, the member may be inappropriately billed. Appeal rights are warranted in both cases, and plans should be prepared to demonstrate delivery of these rights come audit time.
- A proposal to take into account whether sponsor substantially mitigated adverse impact to beneficiaries; in those cases, CMS may remove those where impact was substantially mitigated
- An example is provided, when the beneficiary receives medication within one day of initial rejection.
- Per enrollee aggravating factors now includes reference to inappropriate delay/denial of “appeal rights”
- Think about how multiple aggravating factors will be taken into account using the example provided in the document. For example: if there was a delay in completing a Part D coverage determination, appeal rights were not communicated, but the drug does not generally require access within one day, yet this was a prior offense… if it is not clear to you, then request additional examples or further clarification.
If your organization plans on providing feedback, asking clarifying questions, or providing general comment, make sure you do so in an organized fashion. Don’t have three different people emailing CMS – collaborate, collect, and submit to email@example.com with the subject line 2019 CMP Methodology Comments. The due date/time is April 15, 2019 at 11:59PM Eastern.