Accountability: An Unwritten Element

Last year around this time, we were mulling over the Fall Conference and Webcast delivered by the Centers for Medicare & Medicaid Services (CMS). So much has changed in the way we collaborate and interact with each other, both in our professions and personal lives. With all of us keeping our state and local guidelines in mind, we do our best to keep it compliant so we can stay healthy. The likelihood that we will return to the good old days of Ubering to the CMS Woodlawn office soon are slim.

Since we have a public health emergency that requires us to comply with a set of rules in the spirit of slowing or stopping the spread, I’ve been thinking about accountability. When the unexpected happens, who speaks up? Who takes ownership?

I read a recent compliance and ethics report from LRN which noted that when it comes to compliance failures, a poor culture simply deteriorates standing rules. Culture determines whether policies and guidelines will be followed or ignored. The report also showed that in companies with significant compliance failures, key leaders did not take ownership of the problems. Employees raised concerns and reported either being ignored or pressured to look the other way.

For a policy or a code of conduct to be effective, it cannot simply sit on a shelf. The culture within an organization must promote compliance and ethics to demonstrate accountability. Now that many employees are scattered to the wind, is the corporate culture message getting lost in the fray? If so, I recommend making it a priority to communicate a brief message once a week to remind your team about the organization’s mission, commitment to customers, and culture of compliance. Remember, there is no CMS playbook on culture, but you know it when you see it (and when you don’t!).

You Don’t Need to Drink the Sea: 2021 Program Audit Protocols 30-day Comment

On June 4, 2020, the Centers for Medicare & Medicaid Services released 95 ever-loving pages of industry comments received for the draft 2021 Program Audit protocol. The document includes their responses and actions taken, including what edits they have made to the 60-day package released a few months ago. In my opinion, there is a general feeling of streamlining and simplification to focus on the agency’s areas of priority. 

As I was pulling out clarifications that I am unsure will end up in any FAQ, methodology, or audit process document, I realized the entire responses document should have a proper place on the shelf along with the finalized protocols. Why? Because not all clarifications provided resulted in changes to instructions or data request information. This document can be helpful in communicating expectations to employees and first tier entities alike. 

While it seems like a lot to digest, there was no sign of eliminating an entire review area, or creating a new care delivery branch of review, which is the current focus at the moment due to the public health emergency. If you reviewed the 60-day package thoroughly, the 74-page crosswalk posted with the 30-day package could be your best friend. Therefore, take the comments, hold a meeting, divide and conquer to make sure your business partners and colleagues understand the changes. Comments on this collection must be received by July 6, 2020.

Proposed Rule CMS-4190-P: Past Performance

Today I want to focus on another aspect of the Centers for Medicare & Medicaid Services (CMS) proposed rule 4190-P, which deals with the review of past performance. This is covered in Title 42 of the Code of Federal Regulations, in Section 422.502 for Medicare Advantage (MA) and 423.503 for Part D. 

In 2005, CMS established that they may deny an application submitted by an organization seeking an MA or Part D contract if the organization had failed to comply with the requirements of a previous MA or Part D contract – meaning, their past performance could influence the decision of CMS to approve a submission, including new applications and expansion requests. About nine years ago, CMS established a rule to place a limit on the time period CMS would review, which ended up being a 14-month window.

2011 was quite a busy year for the agency (when is it not busy!); they released some plans from intermediate sanctions, they provided detailed trainings and clarification on marketing guidelines and expectations, and as a boon for enrollees and well-performing organizations, it was the first year a beneficiary could use a special election to join a 5-star plan. How far we have come!

More recently, CMS reduced the look-back period for past performance to 12 months. The most recent review methodology published on January 25, 2019 for the 2020 application cycle consists of 11 performance categories: compliance letters; star ratings; multiple ad-hoc corrective action plans (CAPs); ad hoc CAPs with beneficiary impact; failure to maintain a fiscally sound operation; one-third financial audits; program audits; exclusions; enforcement actions, terminations and non-renewals, and documented significant compliance issues awaiting formal CMS clearance. 

In the proposed rule, CMS suggests adopting three categories: imposition of Civil Money Penalties (CMPs); low star ratings scores, and the failure to maintain a fiscally sound operation. If finalized, they propose to add these three items to their already codified authority. (They state they “decline to consider” an application from an organization still covered by the 2-year prohibition period they agreed to as part of a mutual termination agreement entered into CMS, though the 2021 MA application still includes a waiver request an applicant may complete.)

What would this finalized provision mean for a beneficiary? Medicare beneficiaries should arguably not feel the impact of this change should it be finalized as written. CMS may be narrowing down the categories but the spirit of the past performance review remains the same. As a former colleague once told me about plan expansions, “if you don’t treat your current members right, you do not deserve to grow.” The agency has talked about the importance of beneficiary choice in conferences, and this change, in theory, should only eliminate the possibility of a beneficiary choosing a plan that still needs to get its house in order.

What would this finalized provision mean for a plan? New applicants and existing contract-holders take note: application reviewers are looking at corporate structure and ownership. They ask if any covered person (defined in regulations) served as a covered person for an entity that non-renewed or terminated within the past 2 years. They request organizational charts of the legal entity’s parent organization, affiliates, subsidiaries, and related entities. This is not anticipated to change, and past performance will be applied to applicants that have ties to plans with performance issues.

If finalized with no modifications, I still expect sub-regulatory guidance to be published to provide the industry clarification on whose past performance may be evaluated as part of the application review. Current guidance makes it clear the agency is not intending to be punitive in this process, allowing legal entities with good performance to continue to expand even if the parent organization holds another poor performing contract. 

Proposed Rule CMS-4190-P: Appeal Escalation

Today the Centers for Medicare & Medicaid Services (CMS) published their proposed rule CMS-4190-P. This post focuses on the automatic appeal escalation to external review for Medicare Part D drugs under the Drug Management Program, or DMP.

Background: Under DMPs, a plan engages in case management by contacting prescribers to determine whether a beneficiary is at-risk for misuse or abuse of frequently abused drugs. If a determination is made that the beneficiary is at-risk, the beneficiary is notified in writing and the plan may limit their access to coverage of opioids and/or benzodiazepines to a certain prescriber and/or certain pharmacies. (CMS is proposing to make DMPs mandatory effective January 1, 2022, noting the majority of Part D sponsors have already voluntarily implemented DMPs.)

CMS is also proposing to require the automatic forwarding of redeterminations of a DMP appeal to the independent review entity (IRE) responsible for conducting Part D reconsiderations (Part D level 2 appeals). Medicare Advantage plans have been familiar with the auto-forward requirement for years, as affirmed reconsiderations (Part C level 1 appeals) must be forwarded by the expiration of the adjudication timeframe. However, this process would be new for Part D-only plans such as standalone Prescription Drug Plans, or PDPs, as today only untimely decisions are auto-forwarded to the IRE.

What would this finalized provision mean for a beneficiary? For members who receive an affirmed denial of a DMP appeal, this means their appeal will automatically be forwarded to the IRE. Currently, other affirmed Part D redeterminations are not auto-forwarded. The appellant must make an additional request for an independent review. If this proposal moves forward, those who have been denied their medications due to a DMP decision will be guaranteed that “outside look” to either affirm or overturn the plan’s decision. This streamlines the steps the appellant has to take in this special circumstance. 

What would this finalized provision mean for a plan? If this moves forward, the plan will need to ensure procedures are changed and training is conducted, not only for the appeals department, but also for member services and the case management team working on the DMP decisions. It would be anticipated that member notices would change should this proposed rule become final. Plan and delegate parties to the process must understand how the member’s rights will change. 

Is the volume going to be high? CMS thinks not. The agency expects there will be approximately 28,600 appeals per year, of which 0.08 percent (or 23 cases) will be subject to this auto-forward. Based on this estimate, some plans might never process one of these appeals. However, even if one is received and denied, it is going to be important to auto-forward the case correctly and timely. CMS has been reviewing appeals in their program audit protocol for years, and if this provision is finalized, it could be anticipated DMP appeals may be targeted for sample selection to ensure adherence to the new rule.